{
  "format": "devicerts.device.v1",
  "cite_as": "Canady Flex RoboWrist, Us Medical Innovations, LLC. deviCERTS medical device catalogue. https://devicerts.com/devices/canady-flex-robowrist-gcj (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/canady-flex-robowrist-gcj",
    "json_url": "https://devicerts.com/devices/canady-flex-robowrist-gcj.json",
    "markdown_url": "https://devicerts.com/devices/canady-flex-robowrist-gcj.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/canady-flex-robowrist-gcj",
    "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": "Canady Flex RoboWrist",
    "registry_name": "Canady Flex RoboWrist",
    "url": "https://devicerts.com/devices/canady-flex-robowrist-gcj",
    "manufacturer": {
      "name": "Us Medical Innovations, LLC",
      "url": "https://devicerts.com/manufacturers/us-medical-innovations-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": "K212736",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "GCJ"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Canady Flex RoboWrist is a robotic surgical instrument designed for laparoscopic and open surgical procedures. It is classified under product code GCJ (Gastroenterology, Urology) and is intended to assist surgeons in performing precise, flexible manipulations within confined spaces during minimally invasive surgeries.\n\nThis device is supplied sterile and is intended for single-use. It is regulated under FDA 510(k) clearance (K212736) and is manufactured by US Medical Innovations, LLC. The RoboWrist features articulated wrist mechanics to enhance dexterity, and its design is intended for compatibility with standard laparoscopic ports and surgical settings.",
      "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": "K212736",
      "number_label": null,
      "device_udi_di": null,
      "date": "2022-11-22",
      "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": "K212736",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "GCJ",
              "registries": [
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              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 876.1500",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Gastroenterology, Urology",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
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          "values": [
            {
              "value": "SESE",
              "registries": [
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              ]
            }
          ]
        }
      ]
    }
  ]
}