{
  "format": "devicerts.device.v1",
  "cite_as": "Fraxis Duo, Ilooda.co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/fraxis-duo-gex (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/fraxis-duo-gex",
    "json_url": "https://devicerts.com/devices/fraxis-duo-gex.json",
    "markdown_url": "https://devicerts.com/devices/fraxis-duo-gex.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-15",
    "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/devices/fraxis-duo-gex",
    "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."
  },
  "device": {
    "name": "Fraxis Duo",
    "registry_name": "FRAXIS DUO",
    "url": "https://devicerts.com/devices/fraxis-duo-gex",
    "manufacturer": {
      "name": "Ilooda.co., Ltd",
      "url": "https://devicerts.com/manufacturers/ilooda-co-ltd",
      "country": "South Korea",
      "country_basis": "FDA 510(k) applicant",
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K160312",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "GEX"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Fraxis Duo is a surgical mesh device designed for use in hernia repair procedures. It is classified under the nomenclature for synthetic absorbable or non-absorbable meshes, intended to provide structural support to weakened abdominal walls or inguinal regions.\n\nThis device is supplied sterile, intended for single-use, and is classified under the FDA’s product code GEX (General, Plastic Surgery). It is intended for use in operating room settings and requires proper handling and storage as per manufacturer guidelines. The device holds an FDA 510(k) clearance under the Traditional pathway, with a decision date of October 28, 2016.",
      "ai_generated": true,
      "generated_on": "2026-09-19",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K160312",
      "number_label": null,
      "device_udi_di": null,
      "date": "2016-10-28",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K160312",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "GEX",
              "registries": [
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            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 878.4810",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "General, Plastic Surgery",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
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            }
          ]
        }
      ]
    }
  ]
}