{
  "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": "2026-09-14",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Jacksonville",
      "advisory_committee_description": "Neurology",
      "address_1": "6743 Southpoint Dr. N.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "PGW",
      "openfda": {
        "device_name": "Ear, Nose, And Throat Stereotaxic Instrument",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4560",
        "device_class": "2",
        "registration_number": [
          "3008087383",
          "1811755",
          "8043933",
          "3005423519",
          "3007421149",
          "3009217531",
          "2020550",
          "3015462848",
          "3015967359",
          "9610905",
          "3007738736",
          "3010273872",
          "2183744",
          "3005172759",
          "1058084",
          "3011543740",
          "3011874573",
          "3010009632",
          "3010202439",
          "3003500271",
          "3003418325",
          "1928237",
          "3008203003",
          "3014342096",
          "3015131155",
          "3005677016",
          "1225492",
          "8040510",
          "8010177",
          "3010313588",
          "1221485",
          "3009018440",
          "3018094310",
          "3008837339",
          "3017060084",
          "3007361893",
          "3018565642",
          "1723170",
          "3003678543",
          "9610617",
          "9680721",
          "3006697241",
          "3016245399",
          "3010707607",
          "1824206"
        ],
        "fei_number": [
          "3008087383",
          "1811755",
          "3007421149",
          "3009217531",
          "2020550",
          "3015462848",
          "3015967359",
          "3001237338",
          "3007738736",
          "3010273872",
          "2183744",
          "3005172759",
          "3011543740",
          "3011874573",
          "3010009632",
          "3003500271",
          "3003418325",
          "1928237",
          "3002807464",
          "3008203003",
          "3002808268",
          "3002821504",
          "3014342096",
          "3002619595",
          "3015131155",
          "3005677016",
          "1000244733",
          "3007475226",
          "3010313588",
          "1221485",
          "3009018440",
          "3018094310",
          "3008837339",
          "3001319476",
          "1000517638",
          "3017060084",
          "3007361893",
          "3018565642",
          "3003678543",
          "3006165545",
          "1000221981",
          "3006697241",
          "3016245399",
          "3010707607",
          "1824206"
        ]
      },
      "zip_code": "32216",
      "applicant": "Medtronic Xomed, Inc.",
      "decision_date": "2026-09-04",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexCut ™ Blade with Automated EM Tracking (187BL4060EM);ApexCut ™ Blade with Automated EM Tracking (187BL2975EM);ApexCut ™ Blade with Automated EM Tracking (187BL3590EM);ApexCut ™ Blade with Automated EM Tracking (187BL4000LEM)",
      "advisory_committee": "NE",
      "contact": "Penny  Goodman",
      "expedited_review_flag": "",
      "k_number": "K262235",
      "state": "FL",
      "date_received": "2026-07-01",
      "review_advisory_committee": "EN",
      "postal_code": "32216",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}