{ "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": "2026-04-13", "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": "FGB", "openfda": { "k_number": [ "K240203", "K252468", "K862551", "K233372", "K880801", "K172098", "K992527", "K852888", "K012758", "K062707", "K031278", "K902773", "K233778", "K221158", "K243532", "K233630", "K243155", "K003806", "K872282", "K181451", "K964482", "K926423", "K180367", "K923545", "K252703", "K240074", "K172298", "K982905", "K914106", "K844143", "K062725", "K142556", "K171076", "K243894", "K111480", "K243550", "K023358", "K250049", "K241639", "K183188", "K233645", "K251951", "K000200", "K231135", "K231878", "K033651", "K232911", "K252929", "K911411", "K172246", "K880802", "K241598", "K253411", "K901214", "K011849", "K223466", "K181977", "K884153", "K920750", "K141250", "K250917", "K241434", "K260013", "K963855", "K941013", "K240374", "K223097", "K221515", "K211347", "K900813", "K811535", "K153049", "K043021", "K220159", "K121112", "K131369", "K951855", "K211686", "K222737", "K904793", "K940464", "K230475", "K242108", "K233700", "K925128", "K960323", "K991178", "K242699", "K200369", "K243117", "K233275", "K241945", "K883110", "K011325", "K212458", "K201293", "K990050", "K243708", "K243857", "K213334", "K241956", "K210579", "K230200", "K012951", "K252806", "K926004", "K052044", "K201897", "K250785", "K231774", "K012925", "K970427", "K915458" ], "registration_number": [ "9610773", "2242464", "3016690337", "3003923762", "3006546082", "3014498758", "2183744", "3040391040", "9616693", "3014615697", "3016045249", "9615001", "3000974800", "2936485", "3012375451", "3015970743", "3020369549", "3032959393", "3010202439", "3035710892", "8010047", "3025349506", "3029929134", "3009171251", "3011642792", "1828132", "3035480112", "3011050570", "3010707607", "3010273872", "3022106566", "2030624", "3004040397", "3014644276", "3021031769", "9611102", "9610877", "1000484830", "3013992977", "9614434", "1037955", "3012322232", "2027009", "3004111573", "3003206812", "3017425975", "3037966040", "3000160970", "3002807314", "3013247477", "9610617", "3003790304", "3005941719", "3015540957", "3023809956", "1221826", "3005580113", "3036978610", "1418479", "1519132", "3019807891", "8043903", "3032578846", "3003915875", "3025318945", "3008439484", "8010298", "3017367014", "9610595", "3030504644", "1000121056", "3015139943", "3016881508", "3017210488", "1825146", "3020746799", "3014683069", "2124215", "3033010858", "9611612", "3014342096", "3004644065", "3005173255", "3010419931", "3013687468", "2531475", "3010220595", "8010418", "3002808148", "1820334", "3038613058", "9610691", "3003542872", "3008386005", "3024021261", "3021246306", "3012797688", "3014279513", "1319639", "3028058843", "3005099803", "3014893827", "3008776287", "3009453258", "3015925378", "3003782610", "3032429484", "3038296436", "3012843412", "8010487", "3008998256", "2020550", "3011986317", "3009134855", "3029981244", "3023460764", "3004361445", "9681260", "3035484431" ], "fei_number": [ "2242464", "3016690337", "3003923762", "3006546082", "3008185830", "3014498758", "3002806359", "2183744", "3006149253", "3040391040", "3014615697", "3016045249", "3000974800", "2936485", "3012375451", "3015970743", "3020369549", "3032959393", "3035710892", "3025349506", "3029929134", "3006759904", "3002807795", "3011642792", "1828132", "3035480112", "3011050570", "3010707607", "3002807111", "3010273872", "3022106566", "3007130719", "3004040397", "3021031769", "1000484830", "3002808088", "3013992977", "1037955", "3012322232", "2027009", "3004111573", "3003206812", "3017425975", "3037966040", "3000160970", "3002807314", "3013247477", "3003790304", "3015540957", "3023809956", "1221826", "3005580113", "3036978610", "1418479", "3002807847", "1519132", "3019807891", "3002807798", "3032578846", "3002808001", "3003922255", "3003915875", "3025318945", "3008439484", "3017367014", "3030504644", "1000121056", "3015139943", "3002806565", "3016881508", "3017210488", "3002618605", "1825146", "3020746799", "3014683069", "2124215", "1000138054", "3002808273", "3033010858", "3014342096", "3004644065", "3005173255", "3000206435", "3010419931", "3013687468", "3010220595", "3002808148", "1820334", "3038613058", "3003448211", "3003542872", "3008386005", "3007475226", "3024021261", "3021246306", "3002808268", "3012797688", "3002964398", "3014279513", "3028058843", "4430", "3005099803", "3014893827", "3008776287", "3009453258", "3015925378", "3003782610", "3032429484", "3038296436", "3012843412", "3008998256", "2020550", "3011986317", "3009134855", "3029981244", "3023460764", "3004361445", "3035484431", "3001642379" ] }, "review_panel": "GU", "medical_specialty": "GU", "device_name": "Ureteroscope And Accessories, Flexible/Rigid", "review_code": "", "unclassified_reason": "", "medical_specialty_description": "Gastroenterology, Urology", "device_class": "2", "definition": "To perform various diagnostic and therapeutic procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).", "regulation_number": "876.1500", "implant_flag": "N", "submission_type_id": "1" } ] }