[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PNL":3},{"classification":4,"mappedDevices":41,"similarCandidates":42,"relatedClassifications":122,"syncDates":123,"translation":130,"marketSummary":137,"recalls":152,"k510s":154,"pmas":179},{"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":36,"updated_at":37,"recall_count":38,"latest_recall_date":39,"k510_count":40,"pma_count":38,"event_count":38},6502,"PNL","Magnetic Surgical System","2","878.4815","SU","General, Plastic Surgery","1","System designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures to facilitate access and visualization of the surgical site.  The device is indicated for use in patients within a BMI range of 20 to 34 kg\u002Fm2.  The device is intended for prescription use only.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":33,"device_class":8,"implant_flag":34,"product_code":6,"review_panel":10,"gmp_exempt_flag":34,"third_party_flag":34,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":33,"life_sustain_support_flag":34,"medical_specialty_description":11,"summary_malfunction_reporting":35},{"k_number":17,"fei_number":26,"registration_number":31},[18,19,20,21,22,23,24,25],"K190006","K250746","K191762","DEN150007","K223673","K180894","K252435","K171429",[27,28,29,30],"2219920","3012986524","3000215205","3008791915",[32,27,28,30],"2953359","","N","Eligible","2026-08-18T05:52:53.686257+00:00","2026-08-24T02:00:49.029844+00:00",0,null,8,[],[43,52,60,66,74,81,89,98,105,114],{"medical_device_id":44,"generic_name":45,"class_classification":46,"jmdn_code":47,"name_similarity":48,"definition_similarity":49,"vector_similarity":50,"score":51},1334,"永久磁石式乳房用MR装置","Ⅱ","37659000",0.291667,0.264019,0.672357,0.0287904,{"medical_device_id":53,"generic_name":54,"class_classification":46,"jmdn_code":55,"name_similarity":56,"definition_similarity":57,"vector_similarity":58,"score":59},1460,"磁気刺激装置","36902000",0.294118,0.162963,0.685726,0.0282832,{"medical_device_id":61,"generic_name":62,"class_classification":46,"jmdn_code":63,"name_similarity":48,"definition_similarity":49,"vector_similarity":64,"score":65},1324,"常電導磁石式乳房用MR装置","37611000",0.661169,0.0279843,{"medical_device_id":67,"generic_name":68,"class_classification":46,"jmdn_code":69,"name_similarity":70,"definition_similarity":71,"vector_similarity":72,"score":73},1333,"永久磁石式全身用MR装置","37652000",0.265306,0.221239,0.70139,0.0278937,{"medical_device_id":75,"generic_name":76,"class_classification":46,"jmdn_code":77,"name_similarity":70,"definition_similarity":78,"vector_similarity":79,"score":80},1325,"常電導磁石式全身用MR装置","37653000",0.22049,0.694783,0.0275009,{"medical_device_id":82,"generic_name":83,"class_classification":46,"jmdn_code":84,"name_similarity":85,"definition_similarity":86,"vector_similarity":87,"score":88},1329,"超電導磁石式全身用MR装置","37654000",0.264151,0.232843,0.682993,0.0274328,{"medical_device_id":90,"generic_name":91,"class_classification":92,"jmdn_code":93,"name_similarity":94,"definition_similarity":95,"vector_similarity":96,"score":97},3893,"手術用照明装置","Ⅰ","37332000",0.5,0.137725,0.606266,0.0163934,{"medical_device_id":99,"generic_name":100,"class_classification":92,"jmdn_code":101,"name_similarity":102,"definition_similarity":103,"vector_similarity":104,"score":97},4234,"結石除去用鉗子","35083000",0.0454545,0.227692,0.701504,{"medical_device_id":106,"generic_name":107,"class_classification":108,"jmdn_code":109,"name_similarity":110,"definition_similarity":111,"vector_similarity":112,"score":113},514,"手術用メッシュ","Ⅲ","16048003",0.357143,0.14511,0.597816,0.016129,{"medical_device_id":115,"generic_name":116,"class_classification":108,"jmdn_code":117,"name_similarity":118,"definition_similarity":119,"vector_similarity":120,"score":121},1128,"集束超音波治療器","57888003",0.348837,0.187328,0.62318,0.015873,[],{"510k":124,"classification":125,"enforcement":126,"event":127,"pma":128,"warning_letter":129},"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":131,"definition_ja":132,"commentary_ja":133,"model_name":134,"source_hash":135,"reviewed_by":39,"reviewed_at":39,"created_at":136,"updated_at":136},"磁気式外科手術用胆嚢把持牽引システム","腹腔鏡下胆嚢摘出術において、胆嚢体部および胆嚢底部を把持・牽引し、手術部位へのアクセスおよび視認性を容易にするために設計されたシステムである。本機器は、BMIが20から34 kg\u002Fm2の範囲にある患者への使用が適応とされる。本機器は処方箋によってのみ使用されることが意図されている。","本機器は米国においてクラスIIに分類されており、市販前届出（510(k)）の対象として、既存の類似機器との実質的同等性を示すことにより市販が認められる審査区分となっています。クラスIIは、クラスIより高い規制が必要とされるものの、クラスIIIのように市販前承認（PMA）を要するほどの高いリスクは伴わない機器に適用される区分です。","claude-sonnet-5","170c8b7b8226e0eb2ec4d9a8320d24f4d3d1f53c85d77fb2b6783635a827c28f","2026-08-24T02:33:49.041043+00:00",{"product_code":6,"summary_ja":138,"stats":139,"stats_hash":150,"model_name":134,"created_at":151,"updated_at":151},"510(k)の累計件数は8件で、直近5年では3件、参入企業数は1社となっており、最新の判定は2025年9月です。不具合報告および回収については、いずれも確認されていません。",{"pma":140,"k510":141,"as_of":145,"events":146,"recalls":147,"top_problems":149},{"latest":39,"originals":38,"supplements":38},{"total":40,"last5y":142,"latest":143,"applicants":144},3,"2025-09-26",1,"2026-08",{"death":38,"other":38,"total":38,"injury":38,"last5y":38,"malfunction":38,"latest_month":39},{"total":38,"last5y":38,"latest":39,"class_i":38,"class_ii":38,"class_iii":38,"top_root_causes":148},[],[],"6cdba0220132ecff6d1dc66d4f425b58720d413c610e6c2cbb6d0ad399ce84e2","2026-08-24T05:13:39.867404+00:00",{"items":153,"total":38},[],{"items":155,"total":40},[156,161,163,166,168,170,172,175],{"k_number":24,"device_name":7,"applicant":157,"decision_date":143,"clearance_type":158,"decision_code":159,"statement_or_summary":160},"Levita Magnetics International Corp","Traditional","SESE","Summary",{"k_number":19,"device_name":7,"applicant":157,"decision_date":162,"clearance_type":158,"decision_code":159,"statement_or_summary":160},"2025-06-07",{"k_number":22,"device_name":164,"applicant":157,"decision_date":165,"clearance_type":158,"decision_code":159,"statement_or_summary":160},"Surgeon Controlled Arm","2023-08-04",{"k_number":20,"device_name":7,"applicant":157,"decision_date":167,"clearance_type":158,"decision_code":159,"statement_or_summary":160},"2020-04-01",{"k_number":18,"device_name":7,"applicant":157,"decision_date":169,"clearance_type":158,"decision_code":159,"statement_or_summary":160},"2019-04-29",{"k_number":23,"device_name":7,"applicant":157,"decision_date":171,"clearance_type":158,"decision_code":159,"statement_or_summary":160},"2018-09-19",{"k_number":25,"device_name":7,"applicant":157,"decision_date":173,"clearance_type":174,"decision_code":159,"statement_or_summary":160},"2017-06-06","Special",{"k_number":21,"device_name":7,"applicant":157,"decision_date":176,"clearance_type":177,"decision_code":178,"statement_or_summary":39},"2016-06-13","Direct","DENG",{"items":180,"total":38},[]]