[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NLJ":3},{"classification":4,"mappedDevices":25,"similarCandidates":26,"relatedClassifications":108,"syncDates":117},{"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":20,"updated_at":21,"recall_count":22,"latest_recall_date":23,"k510_count":22,"pma_count":22,"event_count":24},5125,"NLJ","Stripper, Vein, External, Reprocessed","2","870.4885","CV","Cardiovascular","1","Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https:\u002F\u002Fwww.govinfo.gov\u002Fcontent\u002Fpkg\u002FFR-2005-09-29\u002Fpdf\u002F05-19510.pdf).",false,{"openfda":16,"definition":13,"device_name":7,"review_code":17,"device_class":8,"implant_flag":18,"product_code":6,"review_panel":10,"gmp_exempt_flag":18,"third_party_flag":18,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":17,"life_sustain_support_flag":18,"medical_specialty_description":11,"summary_malfunction_reporting":19},{},"","N","Eligible","2026-08-18T05:52:52.566809+00:00","2026-08-18T22:05:38.961415+00:00",0,null,1,[],[27,36,45,54,62,70,78,85,93,100],{"medical_device_id":28,"generic_name":29,"class_classification":30,"jmdn_code":31,"name_similarity":32,"definition_similarity":33,"vector_similarity":34,"score":35},2859,"単回使用血管手術用ストリッパ","Ⅱ","35377002",0.229508,0.187234,0.623299,0.031545,{"medical_device_id":37,"generic_name":38,"class_classification":39,"jmdn_code":40,"name_similarity":41,"definition_similarity":42,"vector_similarity":43,"score":44},4214,"血管手術用ストリッパ","Ⅰ","35377001",0.27451,0.124601,0.601716,0.0310544,{"medical_device_id":46,"generic_name":47,"class_classification":48,"jmdn_code":49,"name_similarity":50,"definition_similarity":51,"vector_similarity":52,"score":53},1161,"再製造心臓用カテーテル型電極","Ⅳ","46359004",0.245902,0.158046,0.589837,0.0292735,{"medical_device_id":55,"generic_name":56,"class_classification":30,"jmdn_code":57,"name_similarity":58,"definition_similarity":59,"vector_similarity":60,"score":61},3204,"再製造腹部用トロカール","61814002",0.285714,0.166113,0.50864,0.0163934,{"medical_device_id":63,"generic_name":64,"class_classification":39,"jmdn_code":65,"name_similarity":66,"definition_similarity":67,"vector_similarity":68,"score":69},3733,"再使用可能なインライン逆流防止バルブ","42548001",0.057971,0.153465,0.617003,0.016129,{"medical_device_id":71,"generic_name":72,"class_classification":30,"jmdn_code":73,"name_similarity":74,"definition_similarity":75,"vector_similarity":76,"score":77},2186,"再使用可能な能動型機器接続用逆流防止バルブ","42548002",0.0481928,0.149321,0.616909,0.015873,{"medical_device_id":79,"generic_name":80,"class_classification":30,"jmdn_code":81,"name_similarity":82,"definition_similarity":83,"vector_similarity":84,"score":77},3205,"再製造リデューサ","70225002",0.26,0.164557,0.552968,{"medical_device_id":86,"generic_name":87,"class_classification":30,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":92},3202,"再製造胸部用トロカール","70218002",0.244898,0.169935,0.507385,0.015625,{"medical_device_id":94,"generic_name":95,"class_classification":39,"jmdn_code":96,"name_similarity":97,"definition_similarity":98,"vector_similarity":99,"score":92},4366,"医療用拡張器","70969001",0.0526316,0.19337,0.609863,{"medical_device_id":101,"generic_name":102,"class_classification":39,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":107},3596,"再使用可能な尖叉試験用針","15679001",0.0350877,0.153488,0.606474,0.0153846,[109,113],{"product_code":110,"device_name":111,"device_class":8,"k510_count":112},"MGZ","Valvulotome",27,{"product_code":114,"device_name":115,"device_class":8,"k510_count":116},"DWQ","Stripper, Vein, External",8,{"510k":118,"classification":119,"enforcement":120,"event":121,"pma":122,"warning_letter":123},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-19T04:07:02.603+00:00"]