[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OJT":3},{"classification":4,"mappedDevices":57,"similarCandidates":58,"relatedClassifications":139,"syncDates":516,"translation":523,"marketSummary":530,"recalls":546,"k510s":548,"pmas":550},{"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":52,"updated_at":53,"recall_count":54,"latest_recall_date":55,"k510_count":54,"pma_count":54,"event_count":56},5453,"OJT","Aspiration Tray","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 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":49,"device_class":8,"implant_flag":50,"product_code":6,"review_panel":10,"gmp_exempt_flag":50,"third_party_flag":50,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":49,"life_sustain_support_flag":50,"medical_specialty_description":11,"summary_malfunction_reporting":51},{"fei_number":17,"registration_number":38},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37],"1625425","3007329020","3005012805","3009888344","3007290840","3004111573","1643817","3003040625","1928237","3015173212","3007139365","1000512168","3001236905","3008002452","1043214","1000112877","1000123297","3002902735","1000112968","1000123180",[39,18,40,19,20,21,41,42,23,43,44,24,26,27,45,28,46,47,32,48],"1123010","1055236","2320762","1054241","1423507","1423537","1061124","8010372","9616088","1123137","","N","Eligible","2026-08-18T05:52:52.566809+00:00","2026-08-24T02:00:49.029844+00:00",0,null,8,[],[59,68,76,85,93,100,108,116,124,131],{"medical_device_id":60,"generic_name":61,"class_classification":62,"jmdn_code":63,"name_similarity":64,"definition_similarity":65,"vector_similarity":66,"score":67},1815,"吸引式組織生検用針キット","Ⅱ","12734020",0.3,0.127036,0.607289,0.0273133,{"medical_device_id":69,"generic_name":70,"class_classification":62,"jmdn_code":71,"name_similarity":72,"definition_similarity":73,"vector_similarity":74,"score":75},1505,"呼吸モジュール","70076000",0.296296,0.167614,0.60216,0.0266901,{"medical_device_id":77,"generic_name":78,"class_classification":79,"jmdn_code":80,"name_similarity":81,"definition_similarity":82,"vector_similarity":83,"score":84},25,"再使用可能な心臓吸引用針","Ⅳ","44136000",0.282051,0.13649,0.603961,0.0250352,{"medical_device_id":86,"generic_name":87,"class_classification":62,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":92},1938,"吸引キット","13846000",0.12,0.175497,0.646283,0.0163934,{"medical_device_id":94,"generic_name":95,"class_classification":62,"jmdn_code":96,"name_similarity":97,"definition_similarity":98,"vector_similarity":99,"score":92},2034,"アスピレート用カテーテル","34894000",0.44,0.1625,0.581468,{"medical_device_id":101,"generic_name":102,"class_classification":62,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":107},2310,"再使用可能な吸引キット","37447000",0.0882353,0.174419,0.64232,0.016129,{"medical_device_id":109,"generic_name":110,"class_classification":111,"jmdn_code":112,"name_similarity":113,"definition_similarity":114,"vector_similarity":115,"score":107},3454,"気管支鏡用吸引チューブ","Ⅰ","16399000",0.352941,0.163987,0.582979,{"medical_device_id":117,"generic_name":118,"class_classification":62,"jmdn_code":119,"name_similarity":120,"definition_similarity":121,"vector_similarity":122,"score":123},2307,"単回使用吸引キット","36142000",0.0857143,0.155779,0.625512,0.015873,{"medical_device_id":125,"generic_name":126,"class_classification":111,"jmdn_code":127,"name_similarity":128,"definition_similarity":129,"vector_similarity":130,"score":123},3608,"再使用可能な吸引用針","37462000",0.354839,0.136076,0.579409,{"medical_device_id":132,"generic_name":133,"class_classification":62,"jmdn_code":134,"name_similarity":135,"definition_similarity":136,"vector_similarity":137,"score":138},1830,"単回使用吸引用針","35886000",0.333333,0.11315,0.565262,0.015625,[140,144,148,152,156,160,164,168,172,176,179,183,187,191,195,199,203,207,211,215,218,222,225,229,233,237,240,244,247,250,254,258,262,265,269,272,275,278,282,285,288,291,294,298,301,305,308,311,314,317,321,324,327,330,333,336,340,343,346,349,352,356,359,362,365,368,371,374,377,380,383,387,390,393,396,399,402,405,408,411,414,417,420,423,426,429,432,435,438,441,444,447,450,453,456,459,462,465,468,471,474,477,480,483,486,489,492,495,498,501,504,507,510,513],{"product_code":141,"device_name":142,"device_class":8,"k510_count":143},"GAA","Needle, Aspiration And Injection, Disposable",107,{"product_code":145,"device_name":146,"device_class":8,"k510_count":147},"GEN","Forceps, General & Plastic Surgery",104,{"product_code":149,"device_name":150,"device_class":8,"k510_count":151},"GAD","Retractor",100,{"product_code":153,"device_name":154,"device_class":8,"k510_count":155},"FSM","Tray, Surgical, Instrument",76,{"product_code":157,"device_name":158,"device_class":8,"k510_count":159},"HTD","Forceps",73,{"product_code":161,"device_name":162,"device_class":8,"k510_count":163},"KDC","Instrument, Surgical, Disposable",67,{"product_code":165,"device_name":166,"device_class":8,"k510_count":167},"KDD","Kit, Surgical Instrument, Disposable",62,{"product_code":169,"device_name":170,"device_class":8,"k510_count":171},"FZT","Cutter, Surgical",52,{"product_code":173,"device_name":174,"device_class":8,"k510_count":175},"GDM","Needle, Aspiration And Injection, Reusable",48,{"product_code":177,"device_name":178,"device_class":8,"k510_count":175},"GES","Blade, Scalpel",{"product_code":180,"device_name":181,"device_class":8,"k510_count":182},"MDM","Instrument, Manual, Surgical, General Use",44,{"product_code":184,"device_name":185,"device_class":8,"k510_count":186},"GEC","Brush, Scrub, Operating-Room",37,{"product_code":188,"device_name":189,"device_class":8,"k510_count":190},"GEA","Cannula, Surgical, General & Plastic Surgery",36,{"product_code":192,"device_name":193,"device_class":8,"k510_count":194},"GDJ","Clamp, Surgical, General & Plastic Surgery",32,{"product_code":196,"device_name":197,"device_class":8,"k510_count":198},"GDF","Guide, Needle, Surgical",28,{"product_code":200,"device_name":201,"device_class":8,"k510_count":202},"GDX","Scalpel, One-Piece",26,{"product_code":204,"device_name":205,"device_class":8,"k510_count":206},"FTY","Tape, Measuring, Rulers And Calipers",23,{"product_code":208,"device_name":209,"device_class":8,"k510_count":210},"LRP","Tray, Surgical",22,{"product_code":212,"device_name":213,"device_class":8,"k510_count":214},"EMF","Knife, Surgical",21,{"product_code":216,"device_name":217,"device_class":8,"k510_count":214},"HTZ","Instrument, Cutting, Orthopedic",{"product_code":219,"device_name":220,"device_class":8,"k510_count":221},"FZX","Guide, Surgical, Instrument",19,{"product_code":223,"device_name":224,"device_class":8,"k510_count":221},"KAM","Cannula, Sinus",{"product_code":226,"device_name":227,"device_class":8,"k510_count":228},"LRW","Scissors, General, Surgical",18,{"product_code":230,"device_name":231,"device_class":8,"k510_count":232},"GDZ","Handle, Scalpel",16,{"product_code":234,"device_name":235,"device_class":8,"k510_count":236},"HRQ","Hemostat",15,{"product_code":238,"device_name":239,"device_class":8,"k510_count":236},"MCZ","Suture Removal Kit",{"product_code":241,"device_name":242,"device_class":8,"k510_count":243},"FZS","Curette, Surgical, General Use",14,{"product_code":245,"device_name":246,"device_class":8,"k510_count":243},"GDO","Applier, Surgical, Clip",{"product_code":248,"device_name":249,"device_class":8,"k510_count":243},"HXD","Clamp",{"product_code":251,"device_name":252,"device_class":8,"k510_count":253},"GEG","Elevator, Surgical, General & Plastic Surgery",12,{"product_code":255,"device_name":256,"device_class":8,"k510_count":257},"DWO","Needle, Biopsy, Cardiovascular",11,{"product_code":259,"device_name":260,"device_class":8,"k510_count":261},"GDG","Hook, Surgical, General & Plastic Surgery",10,{"product_code":263,"device_name":264,"device_class":8,"k510_count":261},"HTC","Pliers, Surgical",{"product_code":266,"device_name":267,"device_class":8,"k510_count":268},"HTR","Rasp",9,{"product_code":270,"device_name":271,"device_class":8,"k510_count":56},"FSH","Tray, Surgical, Needle",{"product_code":273,"device_name":274,"device_class":8,"k510_count":56},"FZW","Expander, Surgical, Skin Graft",{"product_code":276,"device_name":277,"device_class":8,"k510_count":56},"GAB","Needle, Suturing, Disposable",{"product_code":279,"device_name":280,"device_class":8,"k510_count":281},"GAH","Stylet, Surgical, General & Plastic Surgery",7,{"product_code":283,"device_name":284,"device_class":8,"k510_count":281},"GDI","Dissector, Surgical, General & Plastic Surgery",{"product_code":286,"device_name":287,"device_class":8,"k510_count":281},"GEE","Brush, Biopsy, General & Plastic Surgery",{"product_code":289,"device_name":290,"device_class":8,"k510_count":281},"LRY","Punch, Surgical",{"product_code":292,"device_name":293,"device_class":8,"k510_count":281},"MJG","Device, Percutaneous, Biopsy",{"product_code":295,"device_name":296,"device_class":8,"k510_count":297},"GDH","Gouge, Surgical, General & Plastic Surgery",6,{"product_code":299,"device_name":300,"device_class":8,"k510_count":297},"GFI","Osteotome, Manual",{"product_code":302,"device_name":303,"device_class":8,"k510_count":304},"GAF","Spatula, Surgical, General & Plastic Surgery",5,{"product_code":306,"device_name":307,"device_class":8,"k510_count":304},"GCZ","Retainer, Surgical",{"product_code":309,"device_name":310,"device_class":8,"k510_count":304},"GDL","Needle, Suturing, Reusable",{"product_code":312,"device_name":313,"device_class":8,"k510_count":304},"GEJ","Carrier, Ligature",{"product_code":315,"device_name":316,"device_class":8,"k510_count":304},"HCF","Instrument, Ligature Passing And Knot Tying",{"product_code":318,"device_name":319,"device_class":8,"k510_count":320},"FSP","Loupe, Diagnostic\u002FSurgical",4,{"product_code":322,"device_name":323,"device_class":8,"k510_count":320},"GAE","Snare, Surgical",{"product_code":325,"device_name":326,"device_class":8,"k510_count":320},"GEF","Applier, Staple, Surgical,",{"product_code":328,"device_name":329,"device_class":8,"k510_count":320},"HBT","Applier, Hemostatic Clip",{"product_code":331,"device_name":332,"device_class":8,"k510_count":320},"HXR","Spatula, Orthopedic",{"product_code":334,"device_name":335,"device_class":8,"k510_count":320},"LWK","Razor, Surgical",{"product_code":337,"device_name":338,"device_class":8,"k510_count":339},"GFJ","Mallet, Surgical, General & Plastic Surgery",3,{"product_code":341,"device_name":342,"device_class":8,"k510_count":339},"HTF","Curette",{"product_code":344,"device_name":345,"device_class":8,"k510_count":339},"HWM","Osteotome",{"product_code":347,"device_name":348,"device_class":8,"k510_count":339},"HXL","Mallet",{"product_code":350,"device_name":351,"device_class":8,"k510_count":339},"LRZ","Screwdriver, Surgical",{"product_code":353,"device_name":354,"device_class":8,"k510_count":355},"FHM","Apparatus, Suturing, Stomach And Intestinal",2,{"product_code":357,"device_name":358,"device_class":8,"k510_count":355},"FZO","Chisel, Surgical, Manual",{"product_code":360,"device_name":361,"device_class":8,"k510_count":355},"GAC","Rasp, Surgical, General & Plastic Surgery",{"product_code":363,"device_name":364,"device_class":8,"k510_count":355},"GDR","Saw, Manual And Accessories",{"product_code":366,"device_name":367,"device_class":8,"k510_count":355},"GED","Brush, Dermabrasion, Manual",{"product_code":369,"device_name":370,"device_class":8,"k510_count":355},"GEO","File, Surgical, General & Plastic Surgery",{"product_code":372,"device_name":373,"device_class":8,"k510_count":355},"JYC","Cannula, Ear",{"product_code":375,"device_name":376,"device_class":8,"k510_count":355},"LXZ","Guard, Instrument",{"product_code":378,"device_name":379,"device_class":8,"k510_count":355},"LYV","Label Or Tag, Sterile",{"product_code":381,"device_name":382,"device_class":8,"k510_count":355},"PIR","Mercy Tape 2d And 3d Models",{"product_code":384,"device_name":385,"device_class":8,"k510_count":386},"FHR","Needle, Gastro-Urology",1,{"product_code":388,"device_name":389,"device_class":8,"k510_count":386},"FTX","Mirror, General & Plastic Surgery",{"product_code":391,"device_name":392,"device_class":8,"k510_count":386},"FZY","Hammer, Surgical",{"product_code":394,"device_name":395,"device_class":8,"k510_count":386},"GDN","Knife, Amputation",{"product_code":397,"device_name":398,"device_class":8,"k510_count":386},"JYD","Chisel, Mastoid",{"product_code":400,"device_name":401,"device_class":8,"k510_count":386},"KIK","Hook, Bone",{"product_code":403,"device_name":404,"device_class":8,"k510_count":386},"LSA","Vise, Bench, Surgical",{"product_code":406,"device_name":407,"device_class":8,"k510_count":386},"LXK","Scrapper, Skin Specimen",{"product_code":409,"device_name":410,"device_class":8,"k510_count":386},"MAW","Marker, Suture Identification",{"product_code":412,"device_name":413,"device_class":8,"k510_count":386},"OJU","Skin Prep Tray",{"product_code":415,"device_name":416,"device_class":8,"k510_count":386},"QQO","Cranial Measurement Software",{"product_code":418,"device_name":419,"device_class":8,"k510_count":54},"FZR","Contractor, Surgical",{"product_code":421,"device_name":422,"device_class":8,"k510_count":54},"GAI","Stripper, Vein, Reusable",{"product_code":424,"device_name":425,"device_class":8,"k510_count":54},"GAJ","Stripper, Vein, Disposable",{"product_code":427,"device_name":428,"device_class":8,"k510_count":54},"HSO","Saw",{"product_code":430,"device_name":431,"device_class":8,"k510_count":54},"HTE","Elevator",{"product_code":433,"device_name":434,"device_class":8,"k510_count":54},"HXT","Tape, Orthopedic",{"product_code":436,"device_name":437,"device_class":8,"k510_count":54},"HYA","Forceps, Wire Holding",{"product_code":439,"device_name":440,"device_class":8,"k510_count":54},"KAN","Chisel, Nasal",{"product_code":442,"device_name":443,"device_class":8,"k510_count":54},"KCE","Cannulae, Bronchial",{"product_code":445,"device_name":446,"device_class":8,"k510_count":54},"MIJ","Needle, Tumor Localization",{"product_code":448,"device_name":449,"device_class":8,"k510_count":54},"NJZ","Extractor, Vein",{"product_code":451,"device_name":452,"device_class":8,"k510_count":54},"NLK","Needle, Biopsy, Cardiovascular, Reprocessed",{"product_code":454,"device_name":455,"device_class":8,"k510_count":54},"NMU","Needle, Gastro-Urology, Reprocessed",{"product_code":457,"device_name":458,"device_class":8,"k510_count":54},"NNA","Biopsy Device, Percutaneous, Reprocessed",{"product_code":460,"device_name":461,"device_class":8,"k510_count":54},"NNC","Needle, Aspiration And Needle, Reprocessed",{"product_code":463,"device_name":464,"device_class":8,"k510_count":54},"OJH","Orthopedic Tray",{"product_code":466,"device_name":467,"device_class":8,"k510_count":54},"OJV","Single Use Instrument Tray",{"product_code":469,"device_name":470,"device_class":8,"k510_count":54},"PKE","Laparoscopic Cholecystectomy Kit",{"product_code":472,"device_name":473,"device_class":8,"k510_count":54},"PPP","Disposable Joint Aspiration\u002FInjection Kit",{"product_code":475,"device_name":476,"device_class":8,"k510_count":54},"PXN","Basic Set-Up Tray",{"product_code":478,"device_name":479,"device_class":8,"k510_count":54},"PXO","Bone Marrow Biopsy Tray",{"product_code":481,"device_name":482,"device_class":8,"k510_count":54},"PXP","Breast Biopsy \u002F Localization Tray",{"product_code":484,"device_name":485,"device_class":8,"k510_count":54},"PXS","Cholecystectomy Kit",{"product_code":487,"device_name":488,"device_class":8,"k510_count":54},"PXV","General Purpose Instrument Tray",{"product_code":490,"device_name":491,"device_class":8,"k510_count":54},"PXW","Herniorraphy Kit",{"product_code":493,"device_name":494,"device_class":8,"k510_count":54},"PXX","Incision Tray",{"product_code":496,"device_name":497,"device_class":8,"k510_count":54},"PXZ","Laparascopic Sphincterotomy Kit",{"product_code":499,"device_name":500,"device_class":8,"k510_count":54},"PYA","Liver Biopsy Kit",{"product_code":502,"device_name":503,"device_class":8,"k510_count":54},"PYB","Minor Surgical Procedures Tray",{"product_code":505,"device_name":506,"device_class":8,"k510_count":54},"PYD","Pelviscopy Kit",{"product_code":508,"device_name":509,"device_class":8,"k510_count":54},"PYF","Sterile Puncture Tray",{"product_code":511,"device_name":512,"device_class":8,"k510_count":54},"PYH","Surgical Retractor Kit",{"product_code":514,"device_name":515,"device_class":8,"k510_count":54},"QMX","Label Or Tag, Non-Sterile",{"510k":517,"classification":518,"enforcement":519,"event":520,"pma":521,"warning_letter":522},"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":524,"definition_ja":525,"commentary_ja":526,"model_name":527,"source_hash":528,"reviewed_by":55,"reviewed_at":55,"created_at":529,"updated_at":529},"吸引トレイ","この製品コードは、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、市販に際して市販前届出（510(k)）を必要としない。","本製品はクラスIに分類されていますが、通常のクラスI機器とは異なり、FDAが定める「取締裁量（Enforcement Discretion）」という特別な審査区分に位置付けられています。これは、複数の既存機器を組み合わせたコンビニエンスキットについて、ガイダンスに示された基準を満たす限り、市販前届出（510(k)）による審査を経ずに市販できることを意味します。","claude-sonnet-5","8ff67ffb668174e573f86d1147b15ad4084022f299616a91266cb82804f9b317","2026-08-24T02:21:53.785012+00:00",{"product_code":6,"summary_ja":531,"stats":532,"stats_hash":544,"model_name":527,"created_at":545,"updated_at":545},"本製品は取締裁量の対象であり、510(k)およびPMAの届出・承認実績は確認されていません。不具合報告は累計約8件で、大半がMalfunction（不具合）に分類され、死亡・傷害の報告は確認されていません。主な問題としてはMaterial Twisted\u002FBent（材料のねじれ・曲がり）、Difficult to Open or Close（開閉困難）、Physical Resistance\u002FSticking（物理的な抵抗・固着）が挙げられており、最新の報告は2025年5月です。回収については累計件数、クラスI〜IIIのいずれも確認されていません。",{"pma":533,"k510":534,"as_of":535,"events":536,"recalls":538,"top_problems":540},{"latest":55,"originals":54,"supplements":54},{"total":54,"last5y":54,"latest":55,"applicants":54},"2026-08",{"death":54,"other":386,"total":56,"injury":54,"last5y":56,"malfunction":281,"latest_month":537},"2025-05",{"total":54,"last5y":54,"latest":55,"class_i":54,"class_ii":54,"class_iii":54,"top_root_causes":539},[],[541,542,543],"Material Twisted\u002FBent","Difficult to Open or Close","Physical Resistance\u002FSticking","36f811612bb5feae6acf2f72a534253bab39d7fe4bd6fa31a5135b8f671bf0e3","2026-08-24T05:03:24.690751+00:00",{"items":547,"total":54},[],{"items":549,"total":54},[],{"items":551,"total":54},[]]