[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OHL":3},{"classification":4,"mappedDevices":48,"similarCandidates":49,"relatedClassifications":130,"syncDates":266,"translation":273,"marketSummary":280,"recalls":293,"k510s":295,"pmas":297},{"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":43,"updated_at":44,"recall_count":45,"latest_recall_date":46,"k510_count":45,"pma_count":45,"event_count":47},4306,"OHL","Pap Smear Kit","2","884.4530","OB","Obstetrics\u002FGynecology","7","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\u002Fcdrh\u002Fode\u002Fconvkit.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.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":40,"device_class":8,"implant_flag":41,"product_code":6,"review_panel":10,"gmp_exempt_flag":41,"third_party_flag":41,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":40,"life_sustain_support_flag":41,"medical_specialty_description":11,"summary_malfunction_reporting":42},{"fei_number":17,"registration_number":33},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32],"1000112877","3004111573","3006191977","3002902735","1643817","1000512168","3003040625","1000112968","3001236905","3007329020","3009888344","3035642068","3010461097","1043214","1030451",[31,19,34,20,22,35,36,27,28,29,30,37,38,32,39],"1423537","2320762","1055236","9616088","1054241","1061124","","N","Eligible","2026-08-18T05:52:51.740364+00:00","2026-08-24T02:00:49.029844+00:00",0,null,3,[],[50,59,67,75,83,91,99,106,114,122],{"medical_device_id":51,"generic_name":52,"class_classification":53,"jmdn_code":54,"name_similarity":55,"definition_similarity":56,"vector_similarity":57,"score":58},1721,"腎盂鏡検査キット","Ⅱ","32083000",0.208333,0.184211,0.620612,0.0310096,{"medical_device_id":60,"generic_name":61,"class_classification":53,"jmdn_code":62,"name_similarity":63,"definition_similarity":64,"vector_similarity":65,"score":66},2169,"点滴開始キット","33963000",0.178571,0.136213,0.617801,0.0294372,{"medical_device_id":68,"generic_name":69,"class_classification":53,"jmdn_code":70,"name_similarity":71,"definition_similarity":72,"vector_similarity":73,"score":74},1813,"骨盤検査キット","34122000",0.15625,0.118694,0.650768,0.0281772,{"medical_device_id":76,"generic_name":77,"class_classification":53,"jmdn_code":78,"name_similarity":79,"definition_similarity":80,"vector_similarity":81,"score":82},2307,"単回使用吸引キット","36142000",0.16129,0.155779,0.603782,0.0266667,{"medical_device_id":84,"generic_name":85,"class_classification":53,"jmdn_code":86,"name_similarity":87,"definition_similarity":88,"vector_similarity":89,"score":90},2310,"再使用可能な吸引キット","37447000",0.166667,0.174419,0.60089,0.026084,{"medical_device_id":92,"generic_name":93,"class_classification":53,"jmdn_code":94,"name_similarity":95,"definition_similarity":96,"vector_similarity":97,"score":98},1870,"子宮内組織採取キット","11531000",0.147059,0.159892,0.686916,0.0163934,{"medical_device_id":100,"generic_name":101,"class_classification":53,"jmdn_code":102,"name_similarity":103,"definition_similarity":104,"vector_similarity":105,"score":98},2447,"CPAPキット","70579000",0.352941,0.160458,0.5494,{"medical_device_id":107,"generic_name":108,"class_classification":53,"jmdn_code":109,"name_similarity":110,"definition_similarity":111,"vector_similarity":112,"score":113},1938,"吸引キット","13846000",0.238095,0.175497,0.570684,0.016129,{"medical_device_id":115,"generic_name":116,"class_classification":53,"jmdn_code":117,"name_similarity":118,"definition_similarity":119,"vector_similarity":120,"score":121},1985,"泌尿器用カテーテル挿入・採尿キット","14292000",0.0892857,0.147541,0.640235,0.015873,{"medical_device_id":123,"generic_name":124,"class_classification":125,"jmdn_code":126,"name_similarity":127,"definition_similarity":128,"vector_similarity":129,"score":121},3549,"血液塗抹標本作製装置","Ⅰ","15110000",0.230769,0.151134,0.53209,[131,135,139,143,147,151,155,159,164,168,172,175,179,183,187,190,193,196,200,203,207,211,214,217,220,223,227,230,233,236,239,242,245,248,251,254,257,260,263],{"product_code":132,"device_name":133,"device_class":8,"k510_count":134},"LKF","Cannula, Manipulator\u002FInjector, Uterine",87,{"product_code":136,"device_name":137,"device_class":8,"k510_count":138},"HHT","Spatula, Cervical, Cytological",73,{"product_code":140,"device_name":141,"device_class":8,"k510_count":142},"HIB","Speculum, Vaginal, Nonmetal",72,{"product_code":144,"device_name":145,"device_class":8,"k510_count":146},"KNA","Instrument, Manual, Specialized Obstetric-Gynecologic",58,{"product_code":148,"device_name":149,"device_class":8,"k510_count":150},"HFW","Clamp, Umbilical",36,{"product_code":152,"device_name":153,"device_class":8,"k510_count":154},"HFX","Clamp, Circumcision",27,{"product_code":156,"device_name":157,"device_class":8,"k510_count":158},"HCZ","Forceps, Surgical, Gynecological",24,{"product_code":160,"device_name":161,"device_class":162,"k510_count":163},"HFB","Forceps, Biopsy, Gynecological","1",22,{"product_code":165,"device_name":166,"device_class":8,"k510_count":167},"HDC","Tenaculum, Uterine",20,{"product_code":169,"device_name":170,"device_class":162,"k510_count":171},"HCY","Curette, Uterine",11,{"product_code":173,"device_name":174,"device_class":8,"k510_count":171},"OQY","Intrauterine Tamponade Balloon",{"product_code":176,"device_name":177,"device_class":162,"k510_count":178},"HHM","Sound, Uterine",10,{"product_code":180,"device_name":181,"device_class":8,"k510_count":182},"PBQ","Fixation, Non-Absorbable Or Absorbable,  For Pelvic Use",8,{"product_code":184,"device_name":185,"device_class":162,"k510_count":186},"HDQ","Dilator, Cervical, Fixed Size",6,{"product_code":188,"device_name":189,"device_class":162,"k510_count":186},"HGE","Amniotome",{"product_code":191,"device_name":192,"device_class":162,"k510_count":186},"HHF","Remover, Intrauterine Device, Contraceptive, Hook-Type",{"product_code":194,"device_name":195,"device_class":8,"k510_count":186},"MLS","Labor And Delivery Kit",{"product_code":197,"device_name":198,"device_class":8,"k510_count":199},"HIC","Speculum, Vaginal, Nonmetal, Fiberoptic",5,{"product_code":201,"device_name":202,"device_class":8,"k510_count":199},"MOV","Catheters, Salpingography",{"product_code":204,"device_name":205,"device_class":8,"k510_count":206},"HDP","Elevator, Uterine",4,{"product_code":208,"device_name":209,"device_class":8,"k510_count":210},"FHG","Bell, Circumcision",2,{"product_code":212,"device_name":213,"device_class":8,"k510_count":210},"FHJ","Shield, Circumcision",{"product_code":215,"device_name":216,"device_class":8,"k510_count":210},"HHO","Screw, Fibroid, Gynecological",{"product_code":218,"device_name":219,"device_class":8,"k510_count":210},"MPU","Source, Chemiluminescent Light",{"product_code":221,"device_name":222,"device_class":8,"k510_count":210},"PGK","Cannula, Injector, Uterine, Endometrial Biopsy",{"product_code":224,"device_name":225,"device_class":8,"k510_count":226},"LBX","Pelvimeter, Internal",1,{"product_code":228,"device_name":229,"device_class":8,"k510_count":226},"MDG","System, Intrafallopian Cannula",{"product_code":231,"device_name":232,"device_class":8,"k510_count":226},"MLT","Pelvic Exam Kit",{"product_code":234,"device_name":235,"device_class":8,"k510_count":226},"NBZ","Clamp And Cutter, Umbilical",{"product_code":237,"device_name":238,"device_class":162,"k510_count":45},"HDH","Needle, Cerclage, Gynecological",{"product_code":240,"device_name":241,"device_class":8,"k510_count":45},"HDZ","Knife, Cervical Cone",{"product_code":243,"device_name":244,"device_class":8,"k510_count":45},"NMG","Forceps, Biopsy, Gynecological, Reprocessed",{"product_code":246,"device_name":247,"device_class":8,"k510_count":45},"OHG","Circumcision Tray",{"product_code":249,"device_name":250,"device_class":8,"k510_count":45},"OJF","Hysterectomy Kit",{"product_code":252,"device_name":253,"device_class":8,"k510_count":45},"OKY","Cytology Kit",{"product_code":255,"device_name":256,"device_class":8,"k510_count":45},"PUA","Tenaculum, Uterine, Exempt",{"product_code":258,"device_name":259,"device_class":8,"k510_count":45},"PVR","D&C Tray",{"product_code":261,"device_name":262,"device_class":8,"k510_count":45},"PVX","Vaginal Examination Tray",{"product_code":264,"device_name":265,"device_class":8,"k510_count":45},"QQR","Circumcision Device With Stapler",{"510k":267,"classification":268,"enforcement":269,"event":270,"pma":271,"warning_letter":272},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":274,"definition_ja":275,"commentary_ja":276,"model_name":277,"source_hash":278,"reviewed_by":46,"reviewed_at":46,"created_at":279,"updated_at":279},"パップスメアキット","本製品コードは、www.fda.gov\u002Fcdrh\u002Fode\u002Fconvkit.htmlに掲載されている1997年5月20日付ガイダンス「コンビニエンスキットに関する暫定的規制ガイダンス」に従って設定されたものである。上記ガイダンスに記載されているこの種のコンビニエンスキットは、取締裁量の対象であり、ガイダンスに定めるすべての基準を満たす場合、市販するにあたり市販前届出（510(k)）を必要としない。","この製品コードはクラスIIに分類されていますが、通常の510(k)による市販前届出は求められず、FDAの取締裁量の下で規制されています。これは、複数の既存承認済み構成品を組み合わせたコンビニエンスキットに対する簡略的な取り扱いであり、ガイダンスに示された基準を満たす限り、個別の市販前届出手続きを経ずに市場に出すことが認められるものです。","claude-sonnet-5","d62f7ea3a488ba78c9dd08b456fc3592d09ffc73d959776b8cc9641984ed81cd","2026-08-24T02:21:53.785012+00:00",{"product_code":6,"summary_ja":281,"stats":282,"stats_hash":291,"model_name":277,"created_at":292,"updated_at":292},"本製品分類については、510(k)およびPMAの届出・承認実績は確認されていません。不具合報告(MDR)は累計約3件で、大半が不具合(Malfunction)に関するものであり、死亡や傷害の報告は確認されていません。回収についても、これまでの実績は確認されていません。",{"pma":283,"k510":284,"as_of":285,"events":286,"recalls":288,"top_problems":290},{"latest":46,"originals":45,"supplements":45},{"total":45,"last5y":45,"latest":46,"applicants":45},"2026-08",{"death":45,"other":226,"total":47,"injury":45,"last5y":45,"malfunction":210,"latest_month":287},"2016-11",{"total":45,"last5y":45,"latest":46,"class_i":45,"class_ii":45,"class_iii":45,"top_root_causes":289},[],[],"761b83ff967b15d0ab3e31bdd5437188dca342fd434719e727028f30cf3f8d2e","2026-08-24T05:03:24.690751+00:00",{"items":294,"total":45},[],{"items":296,"total":45},[],{"items":298,"total":45},[]]