{
  "format": "devicerts.device.v1",
  "cite_as": "FluidSmart, Thermedx, LLC. deviCERTS medical device catalogue. https://devicerts.com/devices/fluidsmart-hig (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/fluidsmart-hig",
    "json_url": "https://devicerts.com/devices/fluidsmart-hig.json",
    "markdown_url": "https://devicerts.com/devices/fluidsmart-hig.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "registry_records_last_synced": "2026-10-06",
    "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/devices/fluidsmart-hig",
    "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": "FluidSmart",
    "registry_name": "FluidSmart",
    "url": "https://devicerts.com/devices/fluidsmart-hig",
    "manufacturer": {
      "name": "Thermedx, LLC",
      "url": "https://devicerts.com/manufacturers/thermedx-llc",
      "country": "United States",
      "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": "K172048",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "HIG"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "FluidSmart is a hysteroscopic insufflator and fluid management system intended for irrigation, distention, fluid warming, and fluid volume or deficit measurement during endoscopic procedures. It is designed for use in gynecology, urology, and orthopedic disciplines to support laparoscopic and endoscopic interventions.\n\nThe device is supplied as a single-use system and is intended for sterile operation in clinical settings. It is classified under product code HIG and regulated under 21 CFR 884.1700. Storage conditions and handling should follow the manufacturer's operation manual, and the system is designed for single-patient use to maintain sterility and safety.",
      "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": "K172048",
      "number_label": null,
      "device_udi_di": null,
      "date": "2017-09-05",
      "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": [
    {
      "number": "Z-2166-2026",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2026-04-09",
      "reason": "Due to nonconforming products being inadvertently distributed.",
      "applies": "this device",
      "via": "K172048"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K172048",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "HIG",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 884.1700",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Obstetrics/Gynecology",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}