{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "QXG",
      "openfda": {
        "k_number": [
          "DEN220047"
        ]
      },
      "review_panel": "EN",
      "medical_specialty": "EN",
      "device_name": "Cooperative Powered Surgical Assist Device For Ent Surgery",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Ear, Nose, Throat",
      "device_class": "2",
      "definition": "A cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery is a device that facilitates ENT surgical procedures, including instrument placement. The device works in conjunction with the surgeon's movements to assist with precise and stable positioning of an instrument while maintaining the surgeon’s direct physical control of the instrument.",
      "regulation_number": "874.4460",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}