{ "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": "Eligible", "product_code": "LRO", "openfda": { "k_number": [ "K213481", "K932221", "K944044", "K895202", "K965201", "K930270", "K934028", "K854292", "K890570", "K872448", "K910368", "K951149", "K883250", "K962826", "K902293", "K935483", "K925214", "K874439", "K871873", "K932217", "K964921", "K945481", "K952539", "K941846", "K901856", "K964011", "K934029", "K041080", "K935740", "K935743", "K905459", "K933137", "K872011", "K890726", "K885090", "K920292", "K914174", "K970286", "K924468", "K931760", "K871437", "K935686", "K932652", "K934428", "K880942", "K023276", "K931824", "K871322", "K871459", "K971061", "K925016", "K914036", "K934030", "K953083", "K212258", "K935741", "K881083", "K882684", "K945831", "K961863", "K902887", "K922133", "K950295", "K922648", "K903336", "K931673", "K935858", "K880961", "K890658", "K913136", "K970187", "K874760", "K931758", "K914037", "K980137", "K030721", "K890098", "K871434", "K905004", "K890729", "K920267", "K951478", "K893814", "K945160", "K923600", "K936117", "K931759", "K854095", "K963721", "K932220", "K902888", "K931820", "K930700", "K961683", "K894685", "K925216", "K926269", "K963443", "K934688", "K950574", "K873973", "K931844", "K884093", "K914935", "K842648", "K963715", "K971062", "K925467", "K892389", "K910365" ], "registration_number": [ "", "8022032", "3015058854", "3012595397", "3010878085", "3010452421", "9680425", "3020983482", "3042158935", "2648727", "3009203853", "3011494917", "3013466775", "3006973666", "3036002406", "3006673317", "3013421458", "3014421917", "3008824097", "9681709", "3016761372", "3013502418", "1055236", "3010166880", "3013600605", "3035642068", "3004361903", "3008403546", "1061124", "2936485", "2000028362", "1824619", "3010305275", "3005400762", "3003924117", "1018470", "3011270181", "1422634", "3005669815", "1923569", "3043620414", "3006846316", "1047843", "1526711", "3006542380", "9680143", "9611594", "1527607", "3015173212", "1423395", "1123010", "2024311", "9616088", "3005391805", "1066741", "1423537", "9614277", "3030078769", "3004111573", "3003495693", "3005012805", "3007829657", "3019798849", "3004122598", "1610287", "9616096", "3011532690", "1043214", "3017430544", "3006450239", "3002807314", "2029015", "3002806603", "2011171", "3011707784", "1000124971", "3005997949", "3011545608", "1417592", "3006191977", "3014718111", "8030672", "1643817", "2024980", "1644019", "3018077422", "3006540014", "3007344957", "3008496560", "2320762", "1424263", "3011500469", "3017467279", "3007007790", "1055892", "3013298431", "3011554160", "1121203", "3004513970", "3006400329", "3004519921", "1921846", "3031841433", "3004605321", "1047429", "1030451", "3026197444", "2431166", "3009750712", "3009773841", "3015960676", "3004362278", "3006891803", "3018116884", "3002669946", "2433012", "3004713352", "1721686", "3009637528", "3007082897", "3041276890", "3013960812", "3007329020", "3004911384", "1119522", "3010376936", "3006271008", "3011144486", "9611024", "3042480961", "1928237", "1420054", "3015895045", "8030678", "1063382", "3007139365", "3023140882", "3012811961", "1060680", "1650907", "3005595283", "3014680744", "2029275", "3016096096", "3013735189", "9680357", "1065597", "3009888344", "1055954", "3007289408", "1823410", "1054241", "3018071447", "3027977504", "3005246893", "3014704068" ], "fei_number": [ "", "1000113384", "3015058854", "3005596530", "3012595397", "3010878085", "3008875470", "3010452421", "3020983482", "3042158935", "2648727", "3009203853", "3011494917", "3002807170", "3002681132", "3013466775", "3036002406", "3006973666", "3013421458", "3014421917", "1000160458", "3008824097", "1000111202", "3002692512", "3016761372", "3013502418", "2523865", "3010166880", "3013600605", "3035642068", "3004361903", "3008403546", "2936485", "2000028362", "1824619", "3010305275", "3005400762", "3003924117", "1018470", "3011270181", "3000717925", "3005669815", "1923569", "3043620414", "3000718854", "3006846316", "1000123297", "1047843", "1526711", "3006542380", "1527607", "3015173212", "3001236905", "2024311", "3005391805", "3030078769", "3004111573", "3003495693", "3005012805", "3007829657", "3019798849", "3004122598", "1610287", "3003005156", "3011532690", "1043214", "1000514656", "3017430544", "3006450239", "3002807314", "3002806603", "2011171", "3011707784", "1000124971", "1000121355", "3005997949", "3011545608", "1417592", "3000215259", "3006191977", "1643817", "3002806436", "3001717360", "1000112968", "3018077422", "3006540014", "3007344957", "1000208624", "3008496560", "3011500469", "3017467279", "3007007790", "3013298431", "3011554160", "3005846326", "3004513970", "3003807323", "3006400329", "1921846", "3031841433", "3004605321", "1047429", "3194", "1030451", "3026197444", "1000112877", "3009750712", "3009773841", "1000306431", "3002807308", "3015960676", "3004362278", "3004829691", "3018116884", "3002669946", "3003015552", "3006891803", "2433012", "3003040625", "3004713352", "1721686", "3009637528", "3007082897", "3041276890", "3013960812", "3007329020", "3004911384", "1119522", "3010376936", "3003803331", "3006271008", "3011144486", "3042480961", "1928237", "1420054", "3015895045", "3007139365", "3023140882", "3002805559", "3012811961", "3007596547", "3005595283", "3014680744", "1000117501", "1000512168", "3016096096", "3013735189", "3009888344", "3007289408", "1823410", "3008373372", "3018071447", "3027977504", "3005246893", "3014704068", "3002902735" ] }, "review_panel": "SU", "medical_specialty": "SU", "device_name": "General Surgery Tray", "review_code": "", "unclassified_reason": "", "medical_specialty_description": "General, Plastic Surgery", "device_class": "2", "definition": "This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance", "regulation_number": "878.4370", "implant_flag": "N", "submission_type_id": "7" } ] }