{
  "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": "2026-05-25",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Palm Harbor",
      "advisory_committee_description": "Gastroenterology, Urology",
      "address_1": "1247 Florida Ave.",
      "address_2": "",
      "statement_or_summary": "Statement",
      "product_code": "FGM",
      "openfda": {
        "registration_number": [
          "",
          "3010170586",
          "3006487092",
          "1423537",
          "3006128100",
          "9610612",
          "3014334038",
          "3015512299",
          "8040884",
          "9616250",
          "2431166",
          "3005809810",
          "3036795921",
          "9680518",
          "8044098",
          "3005067367",
          "9616088",
          "1421101",
          "3015895045",
          "3021680161",
          "3005695838",
          "3004608878",
          "9610621",
          "9681540",
          "3001644167",
          "3004001706",
          "9611102",
          "5906",
          "3004361445",
          "9710524",
          "1923569",
          "8040179",
          "1058726",
          "9611112",
          "2511556",
          "9611503",
          "3004598675",
          "3016825318",
          "1720747",
          "3035708926",
          "3033536312",
          "9680002",
          "3014201171",
          "8030607",
          "1643817",
          "3009513193",
          "1820334",
          "3027556548",
          "3031564283",
          "3013358456",
          "3012185136",
          "3005440795",
          "8040278",
          "3008936260",
          "3009888344",
          "3008338766",
          "3003418325",
          "1836161",
          "1057946",
          "3006554912",
          "2521453",
          "3023657851",
          "3003431869",
          "3022862651",
          "3004215117",
          "3029082594",
          "2916714",
          "3034532468",
          "3005528784",
          "9611283",
          "3008864603",
          "1417592",
          "3012995405",
          "9613079",
          "8010591",
          "3008770252",
          "3011499367",
          "8010099",
          "3031231776",
          "3010699884",
          "8010665",
          "8040233",
          "3002834291",
          "3010041511",
          "8043816",
          "9614062",
          "1646747",
          "9680515",
          "1421879",
          "9612074",
          "8010547",
          "3007773213",
          "3035678069",
          "3007137643",
          "3011585752",
          "1721676",
          "3010687973",
          "9610905",
          "3012507533",
          "9680718",
          "1315756",
          "3004168759",
          "3007648354",
          "3011137372"
        ],
        "fei_number": [
          "",
          "3003944071",
          "3010170586",
          "3006487092",
          "3006128100",
          "1000115048",
          "3014334038",
          "3015512299",
          "3002806315",
          "3002806450",
          "3005734757",
          "3006509795",
          "1000168975",
          "3005809810",
          "1000307733",
          "3000280067",
          "3036795921",
          "1421101",
          "3015895045",
          "1000405819",
          "3021680161",
          "3005695838",
          "3004608878",
          "3003772581",
          "3003499455",
          "3001644167",
          "1000160162",
          "3005649458",
          "3004001706",
          "3002806816",
          "3374",
          "5906",
          "3004361445",
          "3000321209",
          "1923569",
          "3008782585",
          "5870",
          "3002808001",
          "3546",
          "2511556",
          "1000525271",
          "3004028763",
          "3004598675",
          "3016825318",
          "1720747",
          "3035708926",
          "3033536312",
          "3004216008",
          "3014201171",
          "1643817",
          "3002807072",
          "3009513193",
          "1820334",
          "3027556548",
          "3031564283",
          "3005969827",
          "3013358456",
          "3012185136",
          "3005304066",
          "3005440795",
          "3008936260",
          "3009888344",
          "3008338766",
          "3003418325",
          "3006554912",
          "2521453",
          "3023657851",
          "3003431869",
          "3022862651",
          "3004215117",
          "3029082594",
          "2916714",
          "2523865",
          "3034532468",
          "3005528784",
          "3008864603",
          "1417592",
          "3012995405",
          "3008770252",
          "3002807682",
          "3011499367",
          "3002902735",
          "3031231776",
          "3010699884",
          "3002750084",
          "3002834291",
          "3010041511",
          "3002807464",
          "3007773213",
          "3035678069",
          "3007137643",
          "3011585752",
          "1721676",
          "3010687973",
          "3012507533",
          "3002808335",
          "3002806452",
          "3000183921",
          "1315756",
          "3004168759",
          "3007648354",
          "3001236905",
          "3002807214",
          "3005747797"
        ],
        "device_name": "Probe And Director, Gastro-Urology",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.4730",
        "device_class": "1"
      },
      "zip_code": "34682",
      "applicant": "Regulatory & Marketing Services, Inc.",
      "decision_date": "1995-02-15",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG",
      "advisory_committee": "GU",
      "contact": "PATRICK J LAMB",
      "expedited_review_flag": "",
      "k_number": "K944378",
      "state": "FL",
      "date_received": "1994-09-07",
      "review_advisory_committee": "GU",
      "postal_code": "34682",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}