[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-SAH":3},{"classification":4,"mappedDevices":41,"similarCandidates":42,"relatedClassifications":124,"syncDates":125,"translation":132,"marketSummary":139,"recalls":154,"k510s":156,"pmas":187},{"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":35,"updated_at":36,"recall_count":37,"latest_recall_date":38,"k510_count":39,"pma_count":37,"event_count":40},2082,"SAH","Magnetic Compression Anastomosis System","2","878.4816","SU","General, Plastic Surgery","1","A magnetic compression anastomosis system is a surgical device used for the creation of anastomoses in minimally invasive and laparoscopic surgery in the gastrointestinal tract. The system is comprised of magnet devices and may involve a delivery   system. Compression and necrosis of tissue between magnet devices is created by polar attraction of the magnet devices with healing of tissue around the devices. Once the anastomosis is formed, the magnet devices are expelled naturally. This classification does not include devices intended for weight loss or metabolic disease treatment",false,{"openfda":16,"definition":13,"device_name":7,"review_code":32,"device_class":8,"implant_flag":33,"product_code":6,"review_panel":10,"gmp_exempt_flag":33,"third_party_flag":33,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":32,"life_sustain_support_flag":33,"medical_specialty_description":11,"summary_malfunction_reporting":34},{"k_number":17,"fei_number":26,"registration_number":31},[18,19,20,21,22,23,24,25],"K253550","DEN240013","K243482","K243213","K242086","K253102","K250541","K243359",[27,28,29,30],"3012448339","3021969326","3017462289","1450662",[27,28,29,30],"","N","Ineligible","2026-08-18T05:52:49.993647+00:00","2026-08-24T02:00:49.169481+00:00",0,null,8,1,[],[43,52,60,68,76,84,93,101,108,117],{"medical_device_id":44,"generic_name":45,"class_classification":46,"jmdn_code":47,"name_similarity":48,"definition_similarity":49,"vector_similarity":50,"score":51},1327,"常電導磁石式循環器用MR装置","Ⅱ","37681000",0.242424,0.303419,0.675164,0.0306218,{"medical_device_id":53,"generic_name":54,"class_classification":46,"jmdn_code":55,"name_similarity":56,"definition_similarity":57,"vector_similarity":58,"score":59},1325,"常電導磁石式全身用MR装置","37653000",0.238095,0.261317,0.673175,0.0296703,{"medical_device_id":61,"generic_name":62,"class_classification":46,"jmdn_code":63,"name_similarity":64,"definition_similarity":65,"vector_similarity":66,"score":67},1335,"永久磁石式循環器用MR装置","37682000",0.205882,0.295983,0.680483,0.029236,{"medical_device_id":69,"generic_name":70,"class_classification":46,"jmdn_code":71,"name_similarity":72,"definition_similarity":73,"vector_similarity":74,"score":75},2217,"非吸収性消化器用吻合連結器","18135002",0.2,0.276712,0.699245,0.0287873,{"medical_device_id":77,"generic_name":78,"class_classification":46,"jmdn_code":79,"name_similarity":80,"definition_similarity":81,"vector_similarity":82,"score":83},2218,"血管用吻合連結器","18137002",0.254545,0.214286,0.666101,0.0282187,{"medical_device_id":85,"generic_name":86,"class_classification":87,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":92},493,"非吸収性血管用吻合連結器","Ⅲ","18137003",0.220588,0.188953,0.667488,0.0267094,{"medical_device_id":94,"generic_name":95,"class_classification":46,"jmdn_code":96,"name_similarity":97,"definition_similarity":98,"vector_similarity":99,"score":100},1334,"永久磁石式乳房用MR装置","37659000",0.21875,0.283898,0.661899,0.0266458,{"medical_device_id":102,"generic_name":103,"class_classification":46,"jmdn_code":104,"name_similarity":72,"definition_similarity":105,"vector_similarity":106,"score":107},1333,"永久磁石式全身用MR装置","37652000",0.256619,0.664387,0.0238129,{"medical_device_id":109,"generic_name":110,"class_classification":111,"jmdn_code":112,"name_similarity":113,"definition_similarity":114,"vector_similarity":115,"score":116},158,"吸収性消化器用吻合連結器","Ⅳ","18135004",0.194444,0.250696,0.705555,0.0163934,{"medical_device_id":118,"generic_name":119,"class_classification":46,"jmdn_code":120,"name_similarity":121,"definition_similarity":122,"vector_similarity":123,"score":116},1324,"常電導磁石式乳房用MR装置","37611000",0.258065,0.292111,0.653552,[],{"510k":126,"classification":127,"enforcement":128,"event":129,"pma":130,"warning_letter":131},"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":133,"definition_ja":134,"commentary_ja":135,"model_name":136,"source_hash":137,"reviewed_by":38,"reviewed_at":38,"created_at":138,"updated_at":138},"磁気圧迫吻合システム","磁気圧迫吻合システムは、消化管における低侵襲手術および腹腔鏡下手術において吻合を作成するために使用される外科用機器である。本システムは磁石デバイスから構成され、送達システムを伴う場合がある。磁石デバイス間の組織の圧迫及び壊死は磁石デバイスの極性による吸引力によって生じ、デバイス周囲の組織は治癒する。吻合が形成されると、磁石デバイスは自然に排出される。この分類には、減量又は代謝性疾患治療を目的とするデバイスは含まれない。","本機器は米国においてクラスIIに分類され、市販前届出（510(k)）により安全性と有効性が確認される区分に位置付けられています。510(k)は、既存の同等機器（既承認品）との実質的同等性を示すことで市販が認められる仕組みであり、クラスIIIで求められる市販前承認（PMA）よりも簡略化された審査経路です。","claude-sonnet-5","66be8c77d0b30ae59529e1e72645542935604d52612b7b630da64f7ccf002ee1","2026-08-24T03:37:43.881155+00:00",{"product_code":6,"summary_ja":140,"stats":141,"stats_hash":152,"model_name":136,"created_at":153,"updated_at":153},"510(k)の累計届出件数は8件で、参入企業数は2社、直近5年間の届出も8件となっており、いずれも近年の実績です。不具合報告は累計1件で、傷害報告が1件確認されており、死亡や不具合（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、クラスI・II・IIIいずれも該当がありません。",{"pma":142,"k510":143,"as_of":146,"events":147,"recalls":149,"top_problems":151},{"latest":38,"originals":37,"supplements":37},{"total":39,"last5y":39,"latest":144,"applicants":145},"2026-06-04",2,"2026-08",{"death":37,"other":37,"total":40,"injury":40,"last5y":40,"malfunction":37,"latest_month":148},"2026-06",{"total":37,"last5y":37,"latest":38,"class_i":37,"class_ii":37,"class_iii":37,"top_root_causes":150},[],[],"04f4d9f8ba711b5dede940f667a9672cb27595009b2fe1c3a41b1e99de0314cc","2026-08-24T05:22:13.607018+00:00",{"items":155,"total":37},[],{"items":157,"total":39},[158,164,168,170,173,176,179,182],{"k_number":23,"device_name":159,"applicant":160,"decision_date":144,"clearance_type":161,"decision_code":162,"statement_or_summary":163},"GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)","Gt Metabolic Solutions, Inc.","Traditional","SESE","Summary",{"k_number":18,"device_name":165,"applicant":166,"decision_date":167,"clearance_type":161,"decision_code":162,"statement_or_summary":163},"Self-Forming Magnet (Flexagon Plus OTOLoc)","GI Windows, Inc.","2026-01-09",{"k_number":24,"device_name":165,"applicant":166,"decision_date":169,"clearance_type":161,"decision_code":162,"statement_or_summary":163},"2025-08-01",{"k_number":20,"device_name":171,"applicant":166,"decision_date":172,"clearance_type":161,"decision_code":162,"statement_or_summary":163},"Self-Forming Magnet (Flexagon)","2025-06-11",{"k_number":25,"device_name":174,"applicant":160,"decision_date":175,"clearance_type":161,"decision_code":162,"statement_or_summary":163},"MagDI System (MAG-02, DS-01)","2025-02-28",{"k_number":21,"device_name":177,"applicant":166,"decision_date":178,"clearance_type":161,"decision_code":162,"statement_or_summary":163},"Self-Forming Magnet (FLEX SFM)","2025-01-29",{"k_number":22,"device_name":180,"applicant":160,"decision_date":181,"clearance_type":161,"decision_code":162,"statement_or_summary":163},"MagDI System (MAG-01, DS-01)","2024-10-24",{"k_number":19,"device_name":183,"applicant":160,"decision_date":184,"clearance_type":185,"decision_code":186,"statement_or_summary":38},"MagDI System","2024-07-02","Post-NSE","DENG",{"items":188,"total":37},[]]