{
  "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": "2026-08-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "Y",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "FCM",
      "openfda": {
        "k_number": [
          "K790272",
          "K901180",
          "K011055",
          "K760128",
          "K780268",
          "K901185",
          "K950344",
          "K950092",
          "K951178",
          "K962073",
          "K760127",
          "K250891",
          "K010420",
          "K896212",
          "K002803",
          "K254076",
          "K772341",
          "K950109",
          "K070048",
          "K082831",
          "K910653",
          "K030664",
          "K772342",
          "K901183",
          "K772277",
          "K771103",
          "K960566",
          "K963993",
          "K903340",
          "K923538",
          "K951479",
          "K910022",
          "K780879",
          "K790254",
          "K901184",
          "K772340",
          "K771652",
          "K771651",
          "K780735",
          "K960214",
          "K983010",
          "K780123",
          "K003873",
          "K770496",
          "K960215",
          "K070939",
          "K904158",
          "K790271",
          "K780124",
          "K962254",
          "K771104",
          "K950390",
          "K942177",
          "K760048",
          "K223821",
          "K901181",
          "K771650",
          "K961442",
          "K902508",
          "K030712"
        ],
        "registration_number": [
          "3009609358",
          "9680787",
          "3008806809",
          "2032112",
          "2320762",
          "3045816902",
          "3011987967",
          "2011171",
          "3015142802",
          "8040412",
          "3018116884",
          "9611590",
          "3004365956",
          "1650927",
          "3015176887",
          "3014421917",
          "9610694",
          "3015173212",
          "3006673317",
          "1043214",
          "3011137372",
          "3004727093",
          "3007185216",
          "3004111573",
          "3002993863",
          "1055236",
          "3008191244",
          "3004122598",
          "9610849",
          "3010220595",
          "9612030",
          "3013188547",
          "1423537",
          "1921846",
          "3014404707",
          "3006430057",
          "3017937889",
          "8040607",
          "2320961",
          "3006082230",
          "3022518300",
          "1420054",
          "3006542380",
          "3005012805",
          "1054241",
          "3005669815",
          "3030087693",
          "3017961114",
          "1928237",
          "2648727",
          "3012445205",
          "1018233",
          "3011707784",
          "1480288",
          "3014656749",
          "1647149",
          "2029015"
        ],
        "fei_number": [
          "3009609358",
          "3008806809",
          "3005747797",
          "3003172243",
          "3002807391",
          "3002806731",
          "3045816902",
          "3011987967",
          "2011171",
          "3015142802",
          "3005596530",
          "3018116884",
          "3003040625",
          "3004365956",
          "3015176887",
          "3014421917",
          "3002695476",
          "3015173212",
          "1043214",
          "1000112968",
          "3001236905",
          "1000160458",
          "1000237915",
          "3004727093",
          "3007185216",
          "3004111573",
          "3002993863",
          "3008191244",
          "3004122598",
          "3010220595",
          "3013188547",
          "3014404707",
          "3006430057",
          "1921846",
          "3009271244",
          "3017937889",
          "3006082230",
          "3002826093",
          "3022518300",
          "1420054",
          "3006542380",
          "3005012805",
          "3003076831",
          "3005669815",
          "3030087693",
          "3002806934",
          "3002806591",
          "3017961114",
          "1928237",
          "1000306139",
          "2648727",
          "1000112877",
          "3012445205",
          "1018233",
          "3011707784",
          "1480288",
          "3014656749"
        ]
      },
      "review_panel": "GU",
      "medical_specialty": "GU",
      "device_name": "Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Gastroenterology, Urology",
      "device_class": "2",
      "definition": "",
      "regulation_number": "876.5130",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}