[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PKE":3},{"classification":4,"mappedDevices":38,"similarCandidates":39,"relatedClassifications":120,"syncDates":496},{"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":32,"updated_at":33,"recall_count":34,"latest_recall_date":35,"k510_count":36,"pma_count":36,"event_count":37},1639,"PKE","Laparoscopic Cholecystectomy Kit","1","878.4800","SU","General, Plastic Surgery","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":29,"device_class":8,"implant_flag":30,"product_code":6,"review_panel":10,"gmp_exempt_flag":30,"third_party_flag":30,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":29,"life_sustain_support_flag":30,"medical_specialty_description":11,"summary_malfunction_reporting":31},{"fei_number":17,"registration_number":25},[18,19,20,21,22,23,24],"3004111573","3002902735","1643817","1000512168","3001236905","3007329020","3009888344",[18,26,20,23,24,27,28],"1423537","9616088","1061124","","N","Eligible","2026-08-18T05:52:49.347546+00:00","2026-08-18T22:05:38.961415+00:00",2,"2022-12-21",0,5,[],[40,49,57,65,73,82,90,98,105,113],{"medical_device_id":41,"generic_name":42,"class_classification":43,"jmdn_code":44,"name_similarity":45,"definition_similarity":46,"vector_similarity":47,"score":48},1736,"腹腔鏡キット","Ⅱ","32043000",0.4,0.199461,0.680379,0.0327869,{"medical_device_id":50,"generic_name":51,"class_classification":43,"jmdn_code":52,"name_similarity":53,"definition_similarity":54,"vector_similarity":55,"score":56},1960,"輪状甲状膜切開キット","15028000",0.181818,0.157182,0.627896,0.0282051,{"medical_device_id":58,"generic_name":59,"class_classification":43,"jmdn_code":60,"name_similarity":61,"definition_similarity":62,"vector_similarity":63,"score":64},1721,"腎盂鏡検査キット","32083000",0.170732,0.197297,0.616319,0.0268384,{"medical_device_id":66,"generic_name":67,"class_classification":43,"jmdn_code":68,"name_similarity":69,"definition_similarity":70,"vector_similarity":71,"score":72},1961,"気管切開キット","35403000",0.166667,0.130952,0.59347,0.0235327,{"medical_device_id":74,"generic_name":75,"class_classification":76,"jmdn_code":77,"name_similarity":78,"definition_similarity":79,"vector_similarity":80,"score":81},191,"単回使用クラスⅣ処置キット","Ⅳ","33961004",0.0714286,0.167614,0.64378,0.016129,{"medical_device_id":83,"generic_name":84,"class_classification":85,"jmdn_code":86,"name_similarity":87,"definition_similarity":88,"vector_similarity":89,"score":81},3448,"腹腔鏡用へら","Ⅰ","36083000",0.317073,0.143695,0.553674,{"medical_device_id":91,"generic_name":92,"class_classification":43,"jmdn_code":93,"name_similarity":94,"definition_similarity":95,"vector_similarity":96,"score":97},1481,"膀胱用電極","11436000",0.25,0.151786,0.520591,0.015873,{"medical_device_id":99,"generic_name":100,"class_classification":43,"jmdn_code":101,"name_similarity":102,"definition_similarity":103,"vector_similarity":104,"score":97},1889,"単回使用羊水穿刺キット","35496000",0.0689655,0.132124,0.641151,{"medical_device_id":106,"generic_name":107,"class_classification":43,"jmdn_code":108,"name_similarity":109,"definition_similarity":110,"vector_similarity":111,"score":112},1730,"硬性腹腔鏡","12291000",0.243902,0.184615,0.570202,0.015625,{"medical_device_id":114,"generic_name":115,"class_classification":85,"jmdn_code":116,"name_similarity":117,"definition_similarity":118,"vector_similarity":119,"score":112},3822,"単回使用クラスⅠ処置キット","33961001",0.0724638,0.168067,0.630985,[121,125,129,133,137,141,145,149,153,157,160,164,168,172,176,180,184,188,192,196,199,203,206,210,214,218,221,225,228,231,235,239,243,246,250,254,257,260,264,267,270,273,276,280,283,286,289,292,295,298,302,305,308,311,314,317,321,324,327,330,333,336,339,342,345,348,351,354,357,360,363,367,370,373,376,379,382,385,388,391,394,397,400,403,406,409,412,415,418,421,424,427,430,433,436,439,442,445,448,451,454,457,460,463,466,469,472,475,478,481,484,487,490,493],{"product_code":122,"device_name":123,"device_class":8,"k510_count":124},"GAA","Needle, Aspiration And Injection, Disposable",107,{"product_code":126,"device_name":127,"device_class":8,"k510_count":128},"GEN","Forceps, General & Plastic Surgery",104,{"product_code":130,"device_name":131,"device_class":8,"k510_count":132},"GAD","Retractor",100,{"product_code":134,"device_name":135,"device_class":8,"k510_count":136},"FSM","Tray, Surgical, Instrument",76,{"product_code":138,"device_name":139,"device_class":8,"k510_count":140},"HTD","Forceps",73,{"product_code":142,"device_name":143,"device_class":8,"k510_count":144},"KDC","Instrument, Surgical, Disposable",67,{"product_code":146,"device_name":147,"device_class":8,"k510_count":148},"KDD","Kit, Surgical Instrument, Disposable",62,{"product_code":150,"device_name":151,"device_class":8,"k510_count":152},"FZT","Cutter, Surgical",52,{"product_code":154,"device_name":155,"device_class":8,"k510_count":156},"GDM","Needle, Aspiration And Injection, Reusable",48,{"product_code":158,"device_name":159,"device_class":8,"k510_count":156},"GES","Blade, Scalpel",{"product_code":161,"device_name":162,"device_class":8,"k510_count":163},"MDM","Instrument, Manual, Surgical, General Use",44,{"product_code":165,"device_name":166,"device_class":8,"k510_count":167},"GEC","Brush, Scrub, Operating-Room",37,{"product_code":169,"device_name":170,"device_class":8,"k510_count":171},"GEA","Cannula, Surgical, General & Plastic Surgery",36,{"product_code":173,"device_name":174,"device_class":8,"k510_count":175},"GDJ","Clamp, Surgical, General & Plastic Surgery",32,{"product_code":177,"device_name":178,"device_class":8,"k510_count":179},"GDF","Guide, Needle, Surgical",28,{"product_code":181,"device_name":182,"device_class":8,"k510_count":183},"GDX","Scalpel, One-Piece",26,{"product_code":185,"device_name":186,"device_class":8,"k510_count":187},"FTY","Tape, Measuring, Rulers And Calipers",23,{"product_code":189,"device_name":190,"device_class":8,"k510_count":191},"LRP","Tray, Surgical",22,{"product_code":193,"device_name":194,"device_class":8,"k510_count":195},"EMF","Knife, Surgical",21,{"product_code":197,"device_name":198,"device_class":8,"k510_count":195},"HTZ","Instrument, Cutting, Orthopedic",{"product_code":200,"device_name":201,"device_class":8,"k510_count":202},"FZX","Guide, Surgical, Instrument",19,{"product_code":204,"device_name":205,"device_class":8,"k510_count":202},"KAM","Cannula, Sinus",{"product_code":207,"device_name":208,"device_class":8,"k510_count":209},"LRW","Scissors, General, Surgical",18,{"product_code":211,"device_name":212,"device_class":8,"k510_count":213},"GDZ","Handle, Scalpel",16,{"product_code":215,"device_name":216,"device_class":8,"k510_count":217},"HRQ","Hemostat",15,{"product_code":219,"device_name":220,"device_class":8,"k510_count":217},"MCZ","Suture Removal Kit",{"product_code":222,"device_name":223,"device_class":8,"k510_count":224},"FZS","Curette, Surgical, General Use",14,{"product_code":226,"device_name":227,"device_class":8,"k510_count":224},"GDO","Applier, Surgical, Clip",{"product_code":229,"device_name":230,"device_class":8,"k510_count":224},"HXD","Clamp",{"product_code":232,"device_name":233,"device_class":8,"k510_count":234},"GEG","Elevator, Surgical, General & Plastic Surgery",12,{"product_code":236,"device_name":237,"device_class":8,"k510_count":238},"DWO","Needle, Biopsy, Cardiovascular",11,{"product_code":240,"device_name":241,"device_class":8,"k510_count":242},"GDG","Hook, Surgical, General & Plastic Surgery",10,{"product_code":244,"device_name":245,"device_class":8,"k510_count":242},"HTC","Pliers, Surgical",{"product_code":247,"device_name":248,"device_class":8,"k510_count":249},"HTR","Rasp",9,{"product_code":251,"device_name":252,"device_class":8,"k510_count":253},"FSH","Tray, Surgical, Needle",8,{"product_code":255,"device_name":256,"device_class":8,"k510_count":253},"FZW","Expander, Surgical, Skin Graft",{"product_code":258,"device_name":259,"device_class":8,"k510_count":253},"GAB","Needle, Suturing, Disposable",{"product_code":261,"device_name":262,"device_class":8,"k510_count":263},"GAH","Stylet, Surgical, General & Plastic Surgery",7,{"product_code":265,"device_name":266,"device_class":8,"k510_count":263},"GDI","Dissector, Surgical, General & Plastic Surgery",{"product_code":268,"device_name":269,"device_class":8,"k510_count":263},"GEE","Brush, Biopsy, General & Plastic Surgery",{"product_code":271,"device_name":272,"device_class":8,"k510_count":263},"LRY","Punch, Surgical",{"product_code":274,"device_name":275,"device_class":8,"k510_count":263},"MJG","Device, Percutaneous, Biopsy",{"product_code":277,"device_name":278,"device_class":8,"k510_count":279},"GDH","Gouge, Surgical, General & Plastic Surgery",6,{"product_code":281,"device_name":282,"device_class":8,"k510_count":279},"GFI","Osteotome, Manual",{"product_code":284,"device_name":285,"device_class":8,"k510_count":37},"GAF","Spatula, Surgical, General & Plastic Surgery",{"product_code":287,"device_name":288,"device_class":8,"k510_count":37},"GCZ","Retainer, Surgical",{"product_code":290,"device_name":291,"device_class":8,"k510_count":37},"GDL","Needle, Suturing, Reusable",{"product_code":293,"device_name":294,"device_class":8,"k510_count":37},"GEJ","Carrier, Ligature",{"product_code":296,"device_name":297,"device_class":8,"k510_count":37},"HCF","Instrument, Ligature Passing And Knot Tying",{"product_code":299,"device_name":300,"device_class":8,"k510_count":301},"FSP","Loupe, Diagnostic\u002FSurgical",4,{"product_code":303,"device_name":304,"device_class":8,"k510_count":301},"GAE","Snare, Surgical",{"product_code":306,"device_name":307,"device_class":8,"k510_count":301},"GEF","Applier, Staple, Surgical,",{"product_code":309,"device_name":310,"device_class":8,"k510_count":301},"HBT","Applier, Hemostatic Clip",{"product_code":312,"device_name":313,"device_class":8,"k510_count":301},"HXR","Spatula, Orthopedic",{"product_code":315,"device_name":316,"device_class":8,"k510_count":301},"LWK","Razor, Surgical",{"product_code":318,"device_name":319,"device_class":8,"k510_count":320},"GFJ","Mallet, Surgical, General & Plastic Surgery",3,{"product_code":322,"device_name":323,"device_class":8,"k510_count":320},"HTF","Curette",{"product_code":325,"device_name":326,"device_class":8,"k510_count":320},"HWM","Osteotome",{"product_code":328,"device_name":329,"device_class":8,"k510_count":320},"HXL","Mallet",{"product_code":331,"device_name":332,"device_class":8,"k510_count":320},"LRZ","Screwdriver, Surgical",{"product_code":334,"device_name":335,"device_class":8,"k510_count":34},"FHM","Apparatus, Suturing, Stomach And Intestinal",{"product_code":337,"device_name":338,"device_class":8,"k510_count":34},"FZO","Chisel, Surgical, Manual",{"product_code":340,"device_name":341,"device_class":8,"k510_count":34},"GAC","Rasp, Surgical, General & Plastic Surgery",{"product_code":343,"device_name":344,"device_class":8,"k510_count":34},"GDR","Saw, Manual And Accessories",{"product_code":346,"device_name":347,"device_class":8,"k510_count":34},"GED","Brush, Dermabrasion, Manual",{"product_code":349,"device_name":350,"device_class":8,"k510_count":34},"GEO","File, Surgical, General & Plastic Surgery",{"product_code":352,"device_name":353,"device_class":8,"k510_count":34},"JYC","Cannula, Ear",{"product_code":355,"device_name":356,"device_class":8,"k510_count":34},"LXZ","Guard, Instrument",{"product_code":358,"device_name":359,"device_class":8,"k510_count":34},"LYV","Label Or Tag, Sterile",{"product_code":361,"device_name":362,"device_class":8,"k510_count":34},"PIR","Mercy Tape 2d And 3d Models",{"product_code":364,"device_name":365,"device_class":8,"k510_count":366},"FHR","Needle, Gastro-Urology",1,{"product_code":368,"device_name":369,"device_class":8,"k510_count":366},"FTX","Mirror, General & Plastic Surgery",{"product_code":371,"device_name":372,"device_class":8,"k510_count":366},"FZY","Hammer, Surgical",{"product_code":374,"device_name":375,"device_class":8,"k510_count":366},"GDN","Knife, Amputation",{"product_code":377,"device_name":378,"device_class":8,"k510_count":366},"JYD","Chisel, Mastoid",{"product_code":380,"device_name":381,"device_class":8,"k510_count":366},"KIK","Hook, Bone",{"product_code":383,"device_name":384,"device_class":8,"k510_count":366},"LSA","Vise, Bench, Surgical",{"product_code":386,"device_name":387,"device_class":8,"k510_count":366},"LXK","Scrapper, Skin Specimen",{"product_code":389,"device_name":390,"device_class":8,"k510_count":366},"MAW","Marker, Suture Identification",{"product_code":392,"device_name":393,"device_class":8,"k510_count":366},"OJU","Skin Prep Tray",{"product_code":395,"device_name":396,"device_class":8,"k510_count":366},"QQO","Cranial Measurement Software",{"product_code":398,"device_name":399,"device_class":8,"k510_count":36},"FZR","Contractor, Surgical",{"product_code":401,"device_name":402,"device_class":8,"k510_count":36},"GAI","Stripper, Vein, Reusable",{"product_code":404,"device_name":405,"device_class":8,"k510_count":36},"GAJ","Stripper, Vein, Disposable",{"product_code":407,"device_name":408,"device_class":8,"k510_count":36},"HSO","Saw",{"product_code":410,"device_name":411,"device_class":8,"k510_count":36},"HTE","Elevator",{"product_code":413,"device_name":414,"device_class":8,"k510_count":36},"HXT","Tape, Orthopedic",{"product_code":416,"device_name":417,"device_class":8,"k510_count":36},"HYA","Forceps, Wire Holding",{"product_code":419,"device_name":420,"device_class":8,"k510_count":36},"KAN","Chisel, Nasal",{"product_code":422,"device_name":423,"device_class":8,"k510_count":36},"KCE","Cannulae, Bronchial",{"product_code":425,"device_name":426,"device_class":8,"k510_count":36},"MIJ","Needle, Tumor Localization",{"product_code":428,"device_name":429,"device_class":8,"k510_count":36},"NJZ","Extractor, Vein",{"product_code":431,"device_name":432,"device_class":8,"k510_count":36},"NLK","Needle, Biopsy, Cardiovascular, Reprocessed",{"product_code":434,"device_name":435,"device_class":8,"k510_count":36},"NMU","Needle, Gastro-Urology, Reprocessed",{"product_code":437,"device_name":438,"device_class":8,"k510_count":36},"NNA","Biopsy Device, Percutaneous, Reprocessed",{"product_code":440,"device_name":441,"device_class":8,"k510_count":36},"NNC","Needle, Aspiration And Needle, Reprocessed",{"product_code":443,"device_name":444,"device_class":8,"k510_count":36},"OJH","Orthopedic Tray",{"product_code":446,"device_name":447,"device_class":8,"k510_count":36},"OJT","Aspiration Tray",{"product_code":449,"device_name":450,"device_class":8,"k510_count":36},"OJV","Single Use Instrument Tray",{"product_code":452,"device_name":453,"device_class":8,"k510_count":36},"PPP","Disposable Joint Aspiration\u002FInjection Kit",{"product_code":455,"device_name":456,"device_class":8,"k510_count":36},"PXN","Basic Set-Up Tray",{"product_code":458,"device_name":459,"device_class":8,"k510_count":36},"PXO","Bone Marrow Biopsy Tray",{"product_code":461,"device_name":462,"device_class":8,"k510_count":36},"PXP","Breast Biopsy \u002F Localization Tray",{"product_code":464,"device_name":465,"device_class":8,"k510_count":36},"PXS","Cholecystectomy Kit",{"product_code":467,"device_name":468,"device_class":8,"k510_count":36},"PXV","General Purpose Instrument Tray",{"product_code":470,"device_name":471,"device_class":8,"k510_count":36},"PXW","Herniorraphy Kit",{"product_code":473,"device_name":474,"device_class":8,"k510_count":36},"PXX","Incision Tray",{"product_code":476,"device_name":477,"device_class":8,"k510_count":36},"PXZ","Laparascopic Sphincterotomy Kit",{"product_code":479,"device_name":480,"device_class":8,"k510_count":36},"PYA","Liver Biopsy Kit",{"product_code":482,"device_name":483,"device_class":8,"k510_count":36},"PYB","Minor Surgical Procedures Tray",{"product_code":485,"device_name":486,"device_class":8,"k510_count":36},"PYD","Pelviscopy Kit",{"product_code":488,"device_name":489,"device_class":8,"k510_count":36},"PYF","Sterile Puncture Tray",{"product_code":491,"device_name":492,"device_class":8,"k510_count":36},"PYH","Surgical Retractor Kit",{"product_code":494,"device_name":495,"device_class":8,"k510_count":36},"QMX","Label Or Tag, Non-Sterile",{"510k":497,"classification":498,"enforcement":499,"event":500,"pma":501,"warning_letter":502},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:37:02.918+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]