[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-EGM":3},{"classification":4,"mappedDevices":44,"similarCandidates":45,"relatedClassifications":120,"syncDates":121,"translation":128,"marketSummary":134,"recalls":150,"k510s":152,"pmas":201},{"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},2919,"EGM","Injector, Jet, Mechanical-Powered","2","872.4475","DE","Dental","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":35,"product_code":6,"review_panel":10,"gmp_exempt_flag":35,"third_party_flag":36,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":35,"medical_specialty_description":11,"summary_malfunction_reporting":37},{"k_number":17,"fei_number":29,"registration_number":33},[18,19,20,21,22,23,24,25,26,27,28],"K864732","K083811","K243427","K904279","K790193","K834361","K962017","K821273","K864861","K964802","K864294",[30,31,32],"3002808025","3008579121","2225311",[34,31,32],"9613230","N","Y","Eligible","2026-08-18T05:52:50.495594+00:00","2026-08-24T02:00:47.513022+00:00",0,null,11,4,[],[46,54,61,68,75,82,90,98,106,113],{"medical_device_id":47,"generic_name":48,"class_classification":49,"jmdn_code":50,"name_similarity":51,"definition_similarity":40,"vector_similarity":52,"score":53},2193,"機械式針なし医薬品・ワクチン用注入器","Ⅱ","18069000",0.380282,0.712097,0.0327869,{"medical_device_id":55,"generic_name":56,"class_classification":49,"jmdn_code":57,"name_similarity":58,"definition_similarity":40,"vector_similarity":59,"score":60},1359,"多相電動式造影剤注入装置","40723000",0.301587,0.695193,0.0315136,{"medical_device_id":62,"generic_name":63,"class_classification":49,"jmdn_code":64,"name_similarity":65,"definition_similarity":40,"vector_similarity":66,"score":67},2194,"ガス式針なし医薬品・ワクチン用注入器","42949000",0.277778,0.699822,0.0310544,{"medical_device_id":69,"generic_name":70,"class_classification":49,"jmdn_code":71,"name_similarity":72,"definition_similarity":40,"vector_similarity":73,"score":74},1360,"単相電動式造影剤注入装置","40724000",0.296875,0.682526,0.0301178,{"medical_device_id":76,"generic_name":77,"class_classification":49,"jmdn_code":78,"name_similarity":79,"definition_similarity":40,"vector_similarity":80,"score":81},2190,"医薬品ペン型注入器","70391000",0.270833,0.682565,0.0294118,{"medical_device_id":83,"generic_name":84,"class_classification":85,"jmdn_code":86,"name_similarity":87,"definition_similarity":40,"vector_similarity":88,"score":89},326,"脊椎手術用注入器","Ⅳ","70957000",0.27907,0.670976,0.0290404,{"medical_device_id":91,"generic_name":92,"class_classification":93,"jmdn_code":94,"name_similarity":95,"definition_similarity":40,"vector_similarity":96,"score":97},467,"加圧式医薬品注入器","Ⅲ","12504003",0.234043,0.694816,0.028665,{"medical_device_id":99,"generic_name":100,"class_classification":101,"jmdn_code":102,"name_similarity":103,"definition_similarity":40,"vector_similarity":104,"score":105},3861,"洗浄剤注入用具","Ⅰ","70463000",0.217391,0.695804,0.028125,{"medical_device_id":107,"generic_name":108,"class_classification":49,"jmdn_code":109,"name_similarity":110,"definition_similarity":40,"vector_similarity":111,"score":112},2963,"家庭用電動式吸入器","71021000",0.22807,0.68171,0.0274436,{"medical_device_id":114,"generic_name":115,"class_classification":49,"jmdn_code":116,"name_similarity":117,"definition_similarity":40,"vector_similarity":118,"score":119},2192,"医薬品・ワクチン用注入器","12504002",0.210526,0.685522,0.0269736,[],{"510k":122,"classification":123,"enforcement":124,"event":125,"pma":126,"warning_letter":127},"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":129,"definition_ja":41,"commentary_ja":130,"model_name":131,"source_hash":132,"reviewed_by":41,"reviewed_at":41,"created_at":133,"updated_at":133},"機械式ジェットインジェクター","本機器は米国FDAの規制上クラスIIに分類されており、市販前届出（510(k)）により有効性及び安全性が確認される区分に位置づけられています。クラスIIはクラスIより相対的にリスクが高い機器を対象とし、性能規格や同等性の確認を通じて市販が認められる仕組みとなっています。","claude-sonnet-5","a1a79e7106bbb470a83a4fb6f9958e65830ad44074ed62db70ef0d9bdb0e9b32","2026-08-24T01:48:55.976021+00:00",{"product_code":6,"summary_ja":135,"stats":136,"stats_hash":148,"model_name":131,"created_at":149,"updated_at":149},"510(k)の累計件数は11件で、11社が参入しています。直近5年間の届出は1件、最新の判定は2025年8月です。不具合報告は累計4件で、傷害が2件、その他が2件となっており、死亡・不具合（Malfunction）の報告は確認されていません。回収については累計0件で、記録は確認されていません。",{"pma":137,"k510":138,"as_of":141,"events":142,"recalls":145,"top_problems":147},{"latest":41,"originals":40,"supplements":40},{"total":42,"last5y":139,"latest":140,"applicants":42},1,"2025-08-01","2026-08",{"death":40,"other":143,"total":43,"injury":143,"last5y":40,"malfunction":40,"latest_month":144},2,"2017-09",{"total":40,"last5y":40,"latest":41,"class_i":40,"class_ii":40,"class_iii":40,"top_root_causes":146},[],[],"2cbdf2eddd84cfb148583cfc6de73dcabe3fa1c628c0e28ed72dd5a501ff3d02","2026-08-24T04:17:09.731512+00:00",{"items":151,"total":40},[],{"items":153,"total":42},[154,160,164,168,173,177,181,185,189,193,197],{"k_number":20,"device_name":155,"applicant":156,"decision_date":140,"clearance_type":157,"decision_code":158,"statement_or_summary":159},"QuickSleeper 5","Dentalhitec","Traditional","SESE","Summary",{"k_number":19,"device_name":161,"applicant":162,"decision_date":163,"clearance_type":157,"decision_code":158,"statement_or_summary":159},"W&H HANDPIECE ANESTO, MODEL: RA-5","W&H Dentalwerk Buermoos GmbH","2010-01-14",{"k_number":27,"device_name":165,"applicant":166,"decision_date":167,"clearance_type":157,"decision_code":158,"statement_or_summary":159},"CYBERJET LOCAL ANESTHESIA SYSTEM","Intra Vantage, Inc.","1997-05-27",{"k_number":24,"device_name":169,"applicant":170,"decision_date":171,"clearance_type":157,"decision_code":158,"statement_or_summary":172},"HYPODERMIC JET INJECTION APPARATUS","American Jet Injector Corp.","1996-07-26","Statement",{"k_number":21,"device_name":174,"applicant":175,"decision_date":176,"clearance_type":157,"decision_code":158,"statement_or_summary":41},"PAROJECT ANESTHETIC SYRINGE","Ronvig Instruments, Ltd.","1990-12-07",{"k_number":28,"device_name":178,"applicant":179,"decision_date":180,"clearance_type":157,"decision_code":158,"statement_or_summary":41},"HENKE-JECT PRESSURE SYRINGE (MODIFICATION)","Smith & Nephew, Inc.","1987-11-04",{"k_number":18,"device_name":182,"applicant":183,"decision_date":184,"clearance_type":157,"decision_code":158,"statement_or_summary":41},"GRADTECH SYRINGE SYSTEM","Gradtech","1987-04-15",{"k_number":26,"device_name":186,"applicant":187,"decision_date":188,"clearance_type":157,"decision_code":158,"statement_or_summary":41},"INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM","Instrumentations Unltd.","1987-02-13",{"k_number":23,"device_name":190,"applicant":191,"decision_date":192,"clearance_type":157,"decision_code":158,"statement_or_summary":41},"JSB JET SYRINGE","C.B.S. Biotechnics, Inc.","1984-03-05",{"k_number":25,"device_name":194,"applicant":195,"decision_date":196,"clearance_type":157,"decision_code":158,"statement_or_summary":41},"MAYO SCISSOR STRAIGHT 6 3\u002F4","Conphar, Inc.","1982-05-28",{"k_number":22,"device_name":198,"applicant":199,"decision_date":200,"clearance_type":157,"decision_code":158,"statement_or_summary":41},"MIZZY SYRIJET MARK IV","Mizzy, Inc.","1979-04-23",{"items":202,"total":40},[]]