[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-GXJ":3},{"classification":4,"mappedDevices":63,"similarCandidates":64,"relatedClassifications":135,"syncDates":136,"translation":143,"marketSummary":149,"recalls":164,"k510s":166,"pmas":168},{"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":58,"updated_at":59,"recall_count":60,"latest_recall_date":61,"k510_count":60,"pma_count":60,"event_count":62},926,"GXJ","Punch, Skull","1","882.4750","NE","Neurology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":56,"product_code":6,"review_panel":10,"gmp_exempt_flag":56,"third_party_flag":56,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":56,"medical_specialty_description":11,"summary_malfunction_reporting":57},{"fei_number":17,"registration_number":43},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],"3002750084","3003597504","3006509795","3003244954","3005304066","3005440795","3022862651","3007648354","3008711893","1219518","3002807754","3014615697","1000402972","3015972835","2434839","3546","3002806315","2523865","3015895045","3000280067","3029082594","1720747","3004216008","3002806816","1000140363",[19,44,21,45,23,46,24,25,47,26,27,48,29,49,31,32,50,51,52,36,53,54,55,38,39],"9610612","9680718","1056350","1836161","9613926","9611283","9680518","8040278","8030607","2431166","8010704","3005067367","N","Eligible","2026-08-18T05:52:48.222586+00:00","2026-08-24T02:00:48.758894+00:00",0,null,12,[],[65,73,81,87,94,101,107,115,121,128],{"medical_device_id":66,"generic_name":67,"class_classification":68,"jmdn_code":69,"name_similarity":70,"definition_similarity":60,"vector_similarity":71,"score":72},3788,"再使用可能な手術用パンチ","Ⅰ","35285001",0.241379,0.674825,0.032002,{"medical_device_id":74,"generic_name":75,"class_classification":76,"jmdn_code":77,"name_similarity":78,"definition_similarity":60,"vector_similarity":79,"score":80},2242,"大動脈手術用パンチ","Ⅱ","35285022",0.259259,0.657731,0.0317781,{"medical_device_id":82,"generic_name":83,"class_classification":68,"jmdn_code":84,"name_similarity":85,"definition_similarity":60,"vector_similarity":86,"score":80},3995,"歯科用ラバーダムパンチ","35553000",0.206897,0.710212,{"medical_device_id":88,"generic_name":89,"class_classification":76,"jmdn_code":90,"name_similarity":91,"definition_similarity":60,"vector_similarity":92,"score":93},2241,"単回使用手術用パンチ","35285012",0.233333,0.667675,0.031498,{"medical_device_id":95,"generic_name":96,"class_classification":68,"jmdn_code":97,"name_similarity":98,"definition_similarity":60,"vector_similarity":99,"score":100},4251,"頭部手術用クランプ","35446000",0.230769,0.621892,0.0305504,{"medical_device_id":102,"generic_name":103,"class_classification":68,"jmdn_code":104,"name_similarity":60,"definition_similarity":60,"vector_similarity":105,"score":106},4353,"木製つち","11947020",0.675984,0.016129,{"medical_device_id":108,"generic_name":109,"class_classification":110,"jmdn_code":111,"name_similarity":112,"definition_similarity":60,"vector_similarity":113,"score":114},504,"穿刺部保護パッチ","Ⅲ","70432000",0.16129,0.421301,0.0151515,{"medical_device_id":116,"generic_name":117,"class_classification":68,"jmdn_code":118,"name_similarity":119,"definition_similarity":60,"vector_similarity":120,"score":114},3332,"打診器","11950000",0.0344828,0.656075,{"medical_device_id":122,"generic_name":123,"class_classification":76,"jmdn_code":124,"name_similarity":125,"definition_similarity":60,"vector_similarity":126,"score":127},1862,"ブラキセラピー穿刺セット","70211000",0.147059,0.431135,0.0149254,{"medical_device_id":129,"generic_name":130,"class_classification":110,"jmdn_code":131,"name_similarity":132,"definition_similarity":60,"vector_similarity":133,"score":134},527,"涙点プラグ","36237100",0.137931,0.400568,0.0147059,[],{"510k":137,"classification":138,"enforcement":139,"event":140,"pma":141,"warning_letter":142},"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":144,"definition_ja":61,"commentary_ja":145,"model_name":146,"source_hash":147,"reviewed_by":61,"reviewed_at":61,"created_at":148,"updated_at":148},"頭蓋パンチ","本品は頭蓋骨に穴を開けるために用いられる外科用パンチ器具です。米国ではクラスIに分類されており、市販前届出（510(k)）が免除される区分とされています。これはリスクが比較的低く、既存の性能規格や一般的な管理により安全性・有効性を担保できると判断されている医療機器であることを意味します。","claude-sonnet-5","26634dbb36167ddc33e2c87deddfaf59cd3a1e2ce0a7fd97a210b50064f998be","2026-08-24T01:55:21.85667+00:00",{"product_code":6,"summary_ja":150,"stats":151,"stats_hash":162,"model_name":146,"created_at":163,"updated_at":163},"本製品は届出免除の対象であり、510(k)およびPMAの承認・届出実績は確認されていません。不具合報告は累計約10件で、そのすべてがMalfunction（不具合）であり、死亡・傷害の報告は確認されていません。主な問題としてMaterial Twisted\u002FBent（材料の変形・曲がり）が挙げられており、直近5年では約3件、最新の報告は2024年5月となっています。回収については累計・直近5年ともに実績は確認されていません。",{"pma":152,"k510":153,"as_of":154,"events":155,"recalls":158,"top_problems":160},{"latest":61,"originals":60,"supplements":60},{"total":60,"last5y":60,"latest":61,"applicants":60},"2026-08",{"death":60,"other":60,"total":62,"injury":60,"last5y":156,"malfunction":62,"latest_month":157},3,"2024-05",{"total":60,"last5y":60,"latest":61,"class_i":60,"class_ii":60,"class_iii":60,"top_root_causes":159},[],[161],"Material Twisted\u002FBent","fc00e3048514e691aad2c8dde331b4006cbe877fee32aa8e670fd51b8d73dffd","2026-08-24T04:30:57.116764+00:00",{"items":165,"total":60},[],{"items":167,"total":60},[],{"items":169,"total":60},[]]