[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-KBF":3},{"classification":4,"mappedDevices":44,"similarCandidates":45,"relatedClassifications":116,"syncDates":388,"translation":395,"marketSummary":401,"recalls":415,"k510s":417,"pmas":424},{"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":38,"updated_at":39,"recall_count":40,"latest_recall_date":41,"k510_count":42,"pma_count":40,"event_count":43},6843,"KBF","Trephine, Sinus","1","874.4420","EN","Ear, Nose, Throat","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":36,"product_code":6,"review_panel":10,"gmp_exempt_flag":36,"third_party_flag":36,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":36,"medical_specialty_description":11,"summary_malfunction_reporting":37},{"k_number":17,"fei_number":19,"registration_number":28},[18],"K802915",[20,21,22,23,24,25,26,27],"3002750084","3002409980","3006509795","3017352116","1000194896","3004216008","1000402972","1000160732",[29,30,31,32,33,23,34,35],"1836161","9615857","8040278","8043368","9613926","2085199","8030607","N","Eligible","2026-08-18T05:52:53.686257+00:00","2026-08-24T02:00:49.029844+00:00",0,null,1,2,[],[46,54,61,69,75,82,89,95,102,108],{"medical_device_id":47,"generic_name":48,"class_classification":49,"jmdn_code":50,"name_similarity":51,"definition_similarity":40,"vector_similarity":52,"score":53},4175,"骨トレパン","Ⅰ","14147000",0.473684,0.751292,0.0327869,{"medical_device_id":55,"generic_name":56,"class_classification":49,"jmdn_code":57,"name_similarity":58,"definition_similarity":40,"vector_similarity":59,"score":60},4219,"軟組織トレパン","38440000",0.4,0.718869,0.0322581,{"medical_device_id":62,"generic_name":63,"class_classification":64,"jmdn_code":65,"name_similarity":66,"definition_similarity":40,"vector_similarity":67,"score":68},2841,"単回使用手動式角膜トレパン","Ⅱ","14148012",0.324324,0.705021,0.031498,{"medical_device_id":70,"generic_name":71,"class_classification":49,"jmdn_code":72,"name_similarity":73,"definition_similarity":40,"vector_similarity":74,"score":68},4176,"手動式角膜トレパン","14148001",0.310345,0.705476,{"medical_device_id":76,"generic_name":77,"class_classification":64,"jmdn_code":78,"name_similarity":79,"definition_similarity":40,"vector_similarity":80,"score":81},2557,"ガス式トレパン","32724000",0.30303,0.695433,0.0307692,{"medical_device_id":83,"generic_name":84,"class_classification":64,"jmdn_code":85,"name_similarity":86,"definition_similarity":40,"vector_similarity":87,"score":88},2556,"トレパンシステムコントロールユニット","43928000",0.294118,0.645201,0.0296443,{"medical_device_id":90,"generic_name":91,"class_classification":64,"jmdn_code":92,"name_similarity":93,"definition_similarity":40,"vector_similarity":94,"score":88},2559,"電動式トレパン","32821000",0.238095,0.686137,{"medical_device_id":96,"generic_name":97,"class_classification":64,"jmdn_code":98,"name_similarity":99,"definition_similarity":40,"vector_similarity":100,"score":101},2558,"電池式トレパン","32820000",0.27027,0.674103,0.0296313,{"medical_device_id":103,"generic_name":104,"class_classification":64,"jmdn_code":105,"name_similarity":106,"definition_similarity":40,"vector_similarity":107,"score":101},2560,"電動式角膜トレパン","14148022",0.290323,0.669371,{"medical_device_id":109,"generic_name":110,"class_classification":111,"jmdn_code":112,"name_similarity":113,"definition_similarity":40,"vector_similarity":114,"score":115},50,"冠状静脈洞カニューレ","Ⅳ","36109100",0.193548,0.554901,0.0271062,[117,121,125,129,133,136,140,143,146,149,152,155,159,162,165,168,172,175,178,181,184,187,190,193,196,199,202,205,208,211,214,217,220,223,226,229,232,235,238,241,244,247,250,253,256,259,262,265,268,271,274,277,280,283,286,289,292,295,298,301,304,307,310,313,316,319,322,325,328,331,334,337,340,343,346,349,352,355,358,361,364,367,370,373,376,379,382,385],{"product_code":118,"device_name":119,"device_class":8,"k510_count":120},"LRC","Instrument, Ent Manual Surgical",65,{"product_code":122,"device_name":123,"device_class":8,"k510_count":124},"KAE","Forceps, Ent",14,{"product_code":126,"device_name":127,"device_class":8,"k510_count":128},"KAI","Mirror, Ent",9,{"product_code":130,"device_name":131,"device_class":8,"k510_count":132},"JYG","Curette, Ear",7,{"product_code":134,"device_name":135,"device_class":8,"k510_count":132},"JYO","Knife, Ear",{"product_code":137,"device_name":138,"device_class":8,"k510_count":139},"JYJ","Gauge, Measuring",5,{"product_code":141,"device_name":142,"device_class":8,"k510_count":139},"JYL","Hook, Microsurgical Ear",{"product_code":144,"device_name":145,"device_class":8,"k510_count":139},"JZF","Tube, Ear Suction",{"product_code":147,"device_name":148,"device_class":8,"k510_count":139},"KAD","Elevator, Ent",{"product_code":150,"device_name":151,"device_class":8,"k510_count":139},"KAL","Retractor, Ent",{"product_code":153,"device_name":154,"device_class":8,"k510_count":139},"KTG","Knife, Ent",{"product_code":156,"device_name":157,"device_class":8,"k510_count":158},"JYM","Inserter, Myringotomy Tube",4,{"product_code":160,"device_name":161,"device_class":8,"k510_count":158},"JZB","Scissors, Ear",{"product_code":163,"device_name":164,"device_class":8,"k510_count":158},"KAC","Tube, Laryngectomy",{"product_code":166,"device_name":167,"device_class":8,"k510_count":158},"KBC","Saw, Nasal",{"product_code":169,"device_name":170,"device_class":8,"k510_count":171},"JYS","Perforator, Ear-Lobe",3,{"product_code":173,"device_name":174,"device_class":8,"k510_count":171},"KAR","Irrigator, Sinus",{"product_code":176,"device_name":177,"device_class":8,"k510_count":171},"KBD","Scissors, Nasal",{"product_code":179,"device_name":180,"device_class":8,"k510_count":171},"KBG","Trocar, Sinus",{"product_code":182,"device_name":183,"device_class":8,"k510_count":171},"KBN","Gag, Mouth",{"product_code":185,"device_name":186,"device_class":8,"k510_count":171},"KCD","Bougie, Esophageal, Ent",{"product_code":188,"device_name":189,"device_class":8,"k510_count":171},"KCF","Dilator, Esophageal, Ent",{"product_code":191,"device_name":192,"device_class":8,"k510_count":43},"EWQ","Saw, Surgical, Ent (Electric Or Pneumatic)",{"product_code":194,"device_name":195,"device_class":8,"k510_count":43},"JYQ","Loop, Wire",{"product_code":197,"device_name":198,"device_class":8,"k510_count":43},"JYR","Nipper, Malleus",{"product_code":200,"device_name":201,"device_class":8,"k510_count":43},"JYT","Pick, Microsurgical Ear",{"product_code":203,"device_name":204,"device_class":8,"k510_count":43},"JZD","Snare, Ear",{"product_code":206,"device_name":207,"device_class":8,"k510_count":43},"LJW","Tracheotome",{"product_code":209,"device_name":210,"device_class":8,"k510_count":42},"JYE","Chisel, Middle-Ear",{"product_code":212,"device_name":213,"device_class":8,"k510_count":42},"JYP","Knife, Myringotomy",{"product_code":215,"device_name":216,"device_class":8,"k510_count":42},"JYW","Press, Vein",{"product_code":218,"device_name":219,"device_class":8,"k510_count":42},"JYY","Rasp, Ear",{"product_code":221,"device_name":222,"device_class":8,"k510_count":42},"JYZ","Rod, Measuring Ear",{"product_code":224,"device_name":225,"device_class":8,"k510_count":42},"JZA","Rongeur, Mastoid",{"product_code":227,"device_name":228,"device_class":8,"k510_count":42},"JZE","Spoon, Ear",{"product_code":230,"device_name":231,"device_class":8,"k510_count":42},"KAB","Trocar, Laryngeal",{"product_code":233,"device_name":234,"device_class":8,"k510_count":42},"KAK","Probe, Ent",{"product_code":236,"device_name":237,"device_class":8,"k510_count":42},"KAP","Curette, Nasal",{"product_code":239,"device_name":240,"device_class":8,"k510_count":42},"KAS","Knife, Nasal",{"product_code":242,"device_name":243,"device_class":8,"k510_count":42},"KBH","Adenotome",{"product_code":245,"device_name":246,"device_class":8,"k510_count":42},"KBJ","Curette, Adenoid",{"product_code":248,"device_name":249,"device_class":8,"k510_count":42},"KBL","Depressor, Metal Tongue, Surgical",{"product_code":251,"device_name":252,"device_class":8,"k510_count":42},"KBM","Dissector, Tonsil",{"product_code":254,"device_name":255,"device_class":8,"k510_count":42},"KBO","Guillotine, Tonsil",{"product_code":257,"device_name":258,"device_class":8,"k510_count":42},"KBQ","Knife, Tonsil",{"product_code":260,"device_name":261,"device_class":8,"k510_count":42},"KBW","Screw, Oral",{"product_code":263,"device_name":264,"device_class":8,"k510_count":42},"KBZ","Snare, Tonsil",{"product_code":266,"device_name":267,"device_class":8,"k510_count":42},"KCA","Tonsillectome",{"product_code":269,"device_name":270,"device_class":8,"k510_count":42},"KCB","Tube, Tonsil Suction",{"product_code":272,"device_name":273,"device_class":8,"k510_count":42},"KCG","Dilator, Tracheal",{"product_code":275,"device_name":276,"device_class":8,"k510_count":42},"KTE","Trocar, Ent",{"product_code":278,"device_name":279,"device_class":8,"k510_count":42},"MMO","Tray, Surgical, Ent",{"product_code":281,"device_name":282,"device_class":8,"k510_count":42},"QGK","Balloon, Nasal Airway",{"product_code":284,"device_name":285,"device_class":8,"k510_count":42},"SBS","Laryngeal Injection Set With Led Light",{"product_code":287,"device_name":288,"device_class":8,"k510_count":40},"JYF","Clamp, Ossicle Holding",{"product_code":290,"device_name":291,"device_class":8,"k510_count":40},"JYH","Excavator, Ear",{"product_code":293,"device_name":294,"device_class":8,"k510_count":40},"JYI","Gauge, Mastoid",{"product_code":296,"device_name":297,"device_class":8,"k510_count":40},"JYN","Inserter, Sacculotomy Tack",{"product_code":299,"device_name":300,"device_class":8,"k510_count":40},"JYX","Punch, Attic",{"product_code":302,"device_name":303,"device_class":8,"k510_count":40},"JZC","Searcher, Mastoid",{"product_code":305,"device_name":306,"device_class":8,"k510_count":40},"JZY","Knife, Laryngeal",{"product_code":308,"device_name":309,"device_class":8,"k510_count":40},"JZZ","Saw, Laryngeal",{"product_code":311,"device_name":312,"device_class":8,"k510_count":40},"KAA","Set, Laryngeal Injection",{"product_code":314,"device_name":315,"device_class":8,"k510_count":40},"KAH","Microrule, Ent",{"product_code":317,"device_name":318,"device_class":8,"k510_count":40},"KAJ","Mobilizer, Ent",{"product_code":320,"device_name":321,"device_class":8,"k510_count":40},"KAO","Curette, Ethmoid",{"product_code":323,"device_name":324,"device_class":8,"k510_count":40},"KAQ","Gouge, Nasal, Ent",{"product_code":326,"device_name":327,"device_class":8,"k510_count":40},"KAT","Perforator, Antrum",{"product_code":329,"device_name":330,"device_class":8,"k510_count":40},"KAW","Punch, Antrum",{"product_code":332,"device_name":333,"device_class":8,"k510_count":40},"KAX","Punch, Ethmoid",{"product_code":335,"device_name":336,"device_class":8,"k510_count":40},"KAY","Punch, Nasal",{"product_code":338,"device_name":339,"device_class":8,"k510_count":40},"KAZ","Rasp, Frontal-Sinus",{"product_code":341,"device_name":342,"device_class":8,"k510_count":40},"KBA","Rasp, Nasal",{"product_code":344,"device_name":345,"device_class":8,"k510_count":40},"KBB","Rongeur, Nasal",{"product_code":347,"device_name":348,"device_class":8,"k510_count":40},"KBE","Snare, Nasal",{"product_code":350,"device_name":351,"device_class":8,"k510_count":40},"KBK","Curette, Salpingeal",{"product_code":353,"device_name":354,"device_class":8,"k510_count":40},"KBP","Hook, Tonsil Suturing",{"product_code":356,"device_name":357,"device_class":8,"k510_count":40},"KBR","Needle, Tonsil Suturing",{"product_code":359,"device_name":360,"device_class":8,"k510_count":40},"KBS","Punch, Adenoid",{"product_code":362,"device_name":363,"device_class":8,"k510_count":40},"KBT","Punch, Tonsil",{"product_code":365,"device_name":366,"device_class":8,"k510_count":40},"KBX","Screw, Tonsil",{"product_code":368,"device_name":369,"device_class":8,"k510_count":40},"KCC","Bistoury, Tracheal",{"product_code":371,"device_name":372,"device_class":8,"k510_count":40},"KCH","Hook, Tracheal",{"product_code":374,"device_name":375,"device_class":8,"k510_count":40},"KCI","Trocar, Tracheal",{"product_code":377,"device_name":378,"device_class":8,"k510_count":40},"KTF","Punch, Ent",{"product_code":380,"device_name":381,"device_class":8,"k510_count":40},"NLB","Trocar, Tracheal, Laryngeal, Sinus, Reprocessed",{"product_code":383,"device_name":384,"device_class":8,"k510_count":40},"OGR","Ear, Nose, And Throat Surgical Tray",{"product_code":386,"device_name":387,"device_class":8,"k510_count":40},"OGU","Pierced Ear\u002FEntry Cleaning Tray",{"510k":389,"classification":390,"enforcement":391,"event":392,"pma":393,"warning_letter":394},"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":396,"definition_ja":41,"commentary_ja":397,"model_name":398,"source_hash":399,"reviewed_by":41,"reviewed_at":41,"created_at":400,"updated_at":400},"副鼻腔用トレフィン","本品は、副鼻腔の手術において骨や組織に円筒状の切開・穿孔を行うために用いられる外科用器具です。米国ではクラスIに分類されており、市販前届出（510(k)）の対象からも除外されているため、市販前における個別の届出審査を経ることなく市場に流通させることが可能です。これは、本品が人体へのリスクが低く、一般的な規制（一般的な統制）のみで安全性・有効性が担保できると判断されていることを意味します。","claude-sonnet-5","6c35581e4db5da0cebfdfd518d451359ebd87a19f86429a2f0635ec6600656b4","2026-08-24T02:07:08.607632+00:00",{"product_code":6,"summary_ja":402,"stats":403,"stats_hash":413,"model_name":398,"created_at":414,"updated_at":414},"本製品区分では、510(k)の累計件数は1件で、直近5年間の新規届出は確認されていません。不具合報告は累計2件で、内訳は傷害1件、不具合（Malfunction）1件となっており、死亡報告は確認されていません。回収については累計0件であり、クラスI以下いずれの区分でも報告は確認されていません。",{"pma":404,"k510":405,"as_of":407,"events":408,"recalls":410,"top_problems":412},{"latest":41,"originals":40,"supplements":40},{"total":42,"last5y":40,"latest":406,"applicants":42},"1980-12-19","2026-08",{"death":40,"other":40,"total":43,"injury":42,"last5y":40,"malfunction":42,"latest_month":409},"2008-05",{"total":40,"last5y":40,"latest":41,"class_i":40,"class_ii":40,"class_iii":40,"top_root_causes":411},[],[],"41a034c9958021b9c31777e5a4276a93f05ab2d6196c6f6c11db564e3ec69738","2026-08-24T04:44:46.948226+00:00",{"items":416,"total":40},[],{"items":418,"total":42},[419],{"k_number":18,"device_name":420,"applicant":421,"decision_date":406,"clearance_type":422,"decision_code":423,"statement_or_summary":41},"MONTG. TRACHEAL TREPHINE FENE STRATOR","Boston Medical Products, Inc.","Traditional","SESE",{"items":425,"total":40},[]]