{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Apollo Endosurgery. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/apollo-endosurgery (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/apollo-endosurgery",
    "json_url": "https://devicerts.com/manufacturers/apollo-endosurgery.json",
    "markdown_url": "https://devicerts.com/manufacturers/apollo-endosurgery.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "eudamed_record_synced": null,
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-14",
    "status_as_of": "2026-11-14",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/manufacturers/apollo-endosurgery",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "manufacturer": {
    "name": "Apollo Endosurgery",
    "url": "https://devicerts.com/manufacturers/apollo-endosurgery",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [
      "Apollo Endosurgery, Inc."
    ],
    "country": null,
    "country_basis": null,
    "eudamed_status": null,
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [],
    "identifiers": [],
    "summary": "Apollo Endosurgery is a medical device manufacturer, with 70 devices listed in FDA GUDID and FDA 510(k) (FDA Class III, II and I) and 2 FDA recalls as of 14 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 70,
    "devices_note": null,
    "certificates": 0,
    "fda_recalls_matched_by_name": 2,
    "fda_recalls_ongoing": 0,
    "fda_recalls_ongoing_recent": 0,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 0,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "FDA GUDID",
        "devices": 56
      },
      {
        "registry": "FDA 510(k)",
        "devices": 14
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class III",
        "devices": 35
      },
      {
        "class": "FDA Class II",
        "devices": 31
      },
      {
        "class": "FDA Class I",
        "devices": 4
      }
    ],
    "top_emdn_categories": []
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 50,
    "total": 70,
    "all_devices_url": "https://devicerts.com/manufacturers/apollo-endosurgery",
    "items": [
      {
        "name": "APOLLO ESG Sx™ System APL-ESG-SX1",
        "url": "https://devicerts.com/devices/apollo-esg-sx-system-apl-esg-sx1",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "OverStitch Endoscopic Suturing System PLY-G02-020-APL",
        "url": "https://devicerts.com/devices/overstitch-endoscopic-suturing-system-ply-g02-020-apl",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LAP-BAND AP Adjustable Gastric Banding System B-2245",
        "url": "https://devicerts.com/devices/lap-band-ap-adjustable-gastric-banding-system-b-2245",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "RapidPort EZ Tubing Kit A-20331",
        "url": "https://devicerts.com/devices/rapidport-ez-tubing-kit-a-20331",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LAP-BAND AP Adjustable Gastric Banding System B-2240",
        "url": "https://devicerts.com/devices/lap-band-ap-adjustable-gastric-banding-system-b-2240",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "OverStitch NXT Endoscopic Suturing System ESS-ESG-NXT",
        "url": "https://devicerts.com/devices/overstitch-nxt-endoscopic-suturing-system-ess-esg-nxt",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LAP-BAND System Access Port I Kit B-2104",
        "url": "https://devicerts.com/devices/lap-band-system-access-port-i-kit-b-2104",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "OverStitch NXT Endoscopic Suturing System ESS-G02-NXT",
        "url": "https://devicerts.com/devices/overstitch-nxt-endoscopic-suturing-system-ess-g02-nxt",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LAP-BAND Calibration Tube A-2017",
        "url": "https://devicerts.com/devices/lap-band-calibration-tube-a-2017",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Lap-Band C-2365",
        "url": "https://devicerts.com/devices/lap-band-c-2365",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Lap-Band B-20302",
        "url": "https://devicerts.com/devices/lap-band-b-20302",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "OverStitch Endoscopic Suturing System Sx ESS-G02-Sx1",
        "url": "https://devicerts.com/devices/overstitch-endoscopic-suturing-system-sx-ess-g02-sx1",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "RapidPort EZ C-20390",
        "url": "https://devicerts.com/devices/rapidport-ez-c-20390",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "APOLLO Revise™ System APL-REV-160",
        "url": "https://devicerts.com/devices/apollo-revise-system-apl-rev-160",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Apollo ESG NXT System APL-ESG-NXT",
        "url": "https://devicerts.com/devices/apollo-esg-nxt-system-apl-esg-nxt",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "X-Tack Endoscopic HeliX Tacking System XTACK-235-H",
        "url": "https://devicerts.com/devices/x-tack-endoscopic-helix-tacking-system-xtack-235-h",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "RapidPort EZ C-2306",
        "url": "https://devicerts.com/devices/rapidport-ez-c-2306",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "RapidPort EZ C-2304",
        "url": "https://devicerts.com/devices/rapidport-ez-c-2304",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "The LAP-BAND Adjustable Gastric Banding System with the Access Port II B-2215",
        "url": "https://devicerts.com/devices/the-lap-band-adjustable-gastric-banding-system-with-the-acce-b-2215",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "OverStitch Endoscopic Suturing System ESS-G02-160",
        "url": "https://devicerts.com/devices/overstitch-endoscopic-suturing-system-ess-g02-160",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Access Port RapidPort EZ Kit B-2306",
        "url": "https://devicerts.com/devices/access-port-rapidport-ez-kit-b-2306",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LAP-BAND System Access Port I Kit B-2101",
        "url": "https://devicerts.com/devices/lap-band-system-access-port-i-kit-b-2101",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "X-Tack Endoscopic HeliX Tacking System CNH-C01-213-L",
        "url": "https://devicerts.com/devices/x-tack-endoscopic-helix-tacking-system-cnh-c01-213-l",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "OverTube Endoscopic Access System OVT-027-160",
        "url": "https://devicerts.com/devices/overtube-endoscopic-access-system-ovt-027-160",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Lap-Band B-2017",
        "url": "https://devicerts.com/devices/lap-band-b-2017",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LAP-BAND System Access Port II Kit B-2106",
        "url": "https://devicerts.com/devices/lap-band-system-access-port-ii-kit-b-2106",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LAP-BAND Tubing Kit A-20401",
        "url": "https://devicerts.com/devices/lap-band-tubing-kit-a-20401",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LAP-BAND AP Adjustable Gastric Banding System B-2260",
        "url": "https://devicerts.com/devices/lap-band-ap-adjustable-gastric-banding-system-b-2260",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LAP-BAND System Access Port II Kit B-2103",
        "url": "https://devicerts.com/devices/lap-band-system-access-port-ii-kit-b-2103",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "The LAP-BAND Adjustable Gastric Banding System B-2250",
        "url": "https://devicerts.com/devices/the-lap-band-adjustable-gastric-banding-system-b-2250",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LAP-BAND AP Adjustable Gastric Banding System B-2265",
        "url": "https://devicerts.com/devices/lap-band-ap-adjustable-gastric-banding-system-b-2265",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "APOLLO ESG™ System APL-ESG-160",
        "url": "https://devicerts.com/devices/apollo-esg-system-apl-esg-160",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "NXT Tissue Helix Pro NXT-THXP-130",
        "url": "https://devicerts.com/devices/nxt-tissue-helix-pro-nxt-thxp-130",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Lap-Band B-20401",
        "url": "https://devicerts.com/devices/lap-band-b-20401",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "RapidPort EZ Port Applier Tool B-20390",
        "url": "https://devicerts.com/devices/rapidport-ez-port-applier-tool-b-20390",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "OverStitch Endoscopic Suturing System CNH-G01-000",
        "url": "https://devicerts.com/devices/overstitch-endoscopic-suturing-system-cnh-g01-000",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LAP-BAND AP Adjustable Gastric Banding System with RapidPort EZ B-2360",
        "url": "https://devicerts.com/devices/lap-band-ap-adjustable-gastric-banding-system-with-rapidport-b-2360",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "OverTube Endoscopic Access System OVT-S27-160",
        "url": "https://devicerts.com/devices/overtube-endoscopic-access-system-ovt-s27-160",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ORBERA Intragastric Balloon System B-4800",
        "url": "https://devicerts.com/devices/orbera-intragastric-balloon-system-b-4800",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Apollo Revise NXT System APL-REV-NXT",
        "url": "https://devicerts.com/devices/apollo-revise-nxt-system-apl-rev-nxt",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Lap-Band B-20301",
        "url": "https://devicerts.com/devices/lap-band-b-20301",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LAP-BAND System Access Port II Kit B-2105",
        "url": "https://devicerts.com/devices/lap-band-system-access-port-ii-kit-b-2105",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "APOLLO REVISE™ Sx System APL-REV-Sx1",
        "url": "https://devicerts.com/devices/apollo-revise-sx-system-apl-rev-sx1",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "OverStitch Endoscopic Suturing System THX-165-028",
        "url": "https://devicerts.com/devices/overstitch-endoscopic-suturing-system-thx-165-028",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Access Port RapidPort EZ Kit B-2304",
        "url": "https://devicerts.com/devices/access-port-rapidport-ez-kit-b-2304",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "LAP-BAND System Access Port I Kit B-2107",
        "url": "https://devicerts.com/devices/lap-band-system-access-port-i-kit-b-2107",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Gastric Balloon Suction Catheter B-2020",
        "url": "https://devicerts.com/devices/gastric-balloon-suction-catheter-b-2020",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "X-Tack Endoscopic HeliX Tacking System XTACK-160-H",
        "url": "https://devicerts.com/devices/x-tack-endoscopic-helix-tacking-system-xtack-160-h",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "The LAP-BAND Adjustable Gastric Banding System with the Access Port II B-2225",
        "url": "https://devicerts.com/devices/the-lap-band-adjustable-gastric-banding-system-with-the-acce-b-2225",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "The LAP-BAND Adjustable Gastric Banding System with the Access Port II B-2255",
        "url": "https://devicerts.com/devices/the-lap-band-adjustable-gastric-banding-system-with-the-acce-b-2255",
        "model_reference": null,
        "device_class": "Class III",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": [
    {
      "number": "Z-2743-2018",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2017-11-22",
      "product_code": "LTI",
      "reason": "Component of the Lap-Band system was missing from the package"
    },
    {
      "number": "Z-2732-2014",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2014-08-15",
      "product_code": "LTI",
      "reason": "Product was distributed past its expiration date."
    }
  ]
}