[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PWY":3},{"classification":4,"mappedDevices":51,"similarCandidates":52,"relatedClassifications":133,"syncDates":180},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":45,"updated_at":46,"recall_count":47,"latest_recall_date":48,"k510_count":49,"pma_count":49,"event_count":50},5308,"PWY","Lumbar Puncture Tray (Adult & Pediatric)","2","880.5570","HO","General Hospital","7","This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http:\u002F\u002Fwww.fda.gov\u002Fdownloads\u002FMedicalDevices\u002FDeviceRegulationandGuidance\u002FGuidanceDocuments\u002Fucm080217.pdf.  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.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":42,"device_class":8,"implant_flag":43,"product_code":6,"review_panel":10,"gmp_exempt_flag":43,"third_party_flag":43,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":42,"life_sustain_support_flag":43,"medical_specialty_description":11,"summary_malfunction_reporting":44},{"fei_number":17,"registration_number":34},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33],"1000220280","2433012","3009750712","3004111573","3002902735","3000203000","1921846","1000512168","1643817","3005846326","3001236905","3007329020","3008002452","3009888344","1018470","1824619",[19,20,21,35,36,24,26,37,29,38,39,31,33,32,40,41],"1423507","1423537","3004519921","1061927","1422598","9616088","1061124","","N","Eligible","2026-08-18T05:52:52.566809+00:00","2026-08-18T22:05:38.961415+00:00",21,"2026-07-08",0,57,[],[53,62,71,78,86,94,102,110,118,124],{"medical_device_id":54,"generic_name":55,"class_classification":56,"jmdn_code":57,"name_similarity":58,"definition_similarity":59,"vector_similarity":60,"score":61},3624,"再使用可能な腰椎穿刺キット","Ⅰ","12404001",0.326531,0.105572,0.705574,0.0325225,{"medical_device_id":63,"generic_name":64,"class_classification":65,"jmdn_code":66,"name_similarity":67,"definition_similarity":68,"vector_similarity":69,"score":70},1876,"単回使用腰椎穿刺キット","Ⅱ","12404002",0.313726,0.127717,0.707457,0.0322665,{"medical_device_id":72,"generic_name":73,"class_classification":56,"jmdn_code":74,"name_similarity":67,"definition_similarity":75,"vector_similarity":76,"score":77},3625,"再使用可能な腰椎穿刺用針","34583001",0.140762,0.646096,0.0315136,{"medical_device_id":79,"generic_name":80,"class_classification":65,"jmdn_code":81,"name_similarity":82,"definition_similarity":83,"vector_similarity":84,"score":85},1877,"単回使用腰椎穿刺用針","34583002",0.301887,0.122857,0.662782,0.031498,{"medical_device_id":87,"generic_name":88,"class_classification":65,"jmdn_code":89,"name_similarity":90,"definition_similarity":91,"vector_similarity":92,"score":93},1850,"一時的使用麻酔用穿刺針","70203012",0.166667,0.148883,0.619336,0.0264912,{"medical_device_id":95,"generic_name":96,"class_classification":65,"jmdn_code":97,"name_similarity":98,"definition_similarity":99,"vector_similarity":100,"score":101},1813,"骨盤検査キット","34122000",0.0535714,0.124661,0.649308,0.015625,{"medical_device_id":103,"generic_name":104,"class_classification":65,"jmdn_code":105,"name_similarity":106,"definition_similarity":107,"vector_similarity":108,"score":109},1964,"小児用気管切開チューブ","35404030",0.26,0.204255,0.575286,0.0153846,{"medical_device_id":111,"generic_name":112,"class_classification":65,"jmdn_code":113,"name_similarity":114,"definition_similarity":115,"vector_similarity":116,"score":117},1564,"小児用肺機能分析装置","36134000",0.237288,0.153005,0.48702,0.0151515,{"medical_device_id":119,"generic_name":120,"class_classification":65,"jmdn_code":121,"name_similarity":101,"definition_similarity":122,"vector_similarity":123,"score":117},1889,"単回使用羊水穿刺キット","35496000",0.132124,0.641835,{"medical_device_id":125,"generic_name":126,"class_classification":127,"jmdn_code":128,"name_similarity":129,"definition_similarity":130,"vector_similarity":131,"score":132},358,"脊髄くも膜下・硬膜外針","Ⅲ","36191020",0.0144928,0.164352,0.641371,0.0149254,[134,138,142,146,150,154,158,161,165,168,171,174,177],{"product_code":135,"device_name":136,"device_class":8,"k510_count":137},"FMI","Needle, Hypodermic, Single Lumen",691,{"product_code":139,"device_name":140,"device_class":8,"k510_count":141},"MMK","Container, Sharps",114,{"product_code":143,"device_name":144,"device_class":8,"k510_count":145},"SCL","Allergen And Vaccine Delivery Needles",25,{"product_code":147,"device_name":148,"device_class":8,"k510_count":149},"PTI","Non-Coring (Huber) Needle",13,{"product_code":151,"device_name":152,"device_class":8,"k510_count":153},"QNS","Low Dead Space Needle, Single Lumen, Hypodermic",3,{"product_code":155,"device_name":156,"device_class":8,"k510_count":157},"MHC","Needle, Interosseous",2,{"product_code":159,"device_name":160,"device_class":8,"k510_count":157},"QYM","Ophthalmic Needle",{"product_code":162,"device_name":163,"device_class":8,"k510_count":164},"PVZ","Non-Stainless Steel Needle",1,{"product_code":166,"device_name":167,"device_class":8,"k510_count":49},"NKK","Needle, Hypodermic, Single Lumen, Reprocessed",{"product_code":169,"device_name":170,"device_class":8,"k510_count":49},"PXB","Percutaneous Introducer Kit",{"product_code":172,"device_name":173,"device_class":8,"k510_count":49},"PXI","Thoracentesis Tray",{"product_code":175,"device_name":176,"device_class":8,"k510_count":49},"PXL","Venipuncture Kit",{"product_code":178,"device_name":179,"device_class":8,"k510_count":49},"QMT","Prep Kit  Vaccine Injection",{"510k":181,"classification":182,"enforcement":183,"event":184,"pma":185,"warning_letter":186},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]