[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OXD":3},{"classification":4,"mappedDevices":32,"similarCandidates":33,"relatedClassifications":116,"syncDates":262,"translation":29,"marketSummary":29,"recalls":269,"k510s":271,"pmas":285},{"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":15,"gmp_exempt_flag":15,"raw":16,"created_at":26,"updated_at":27,"recall_count":28,"latest_recall_date":29,"k510_count":30,"pma_count":28,"event_count":31},4702,"OXD","Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement","2","878.3300","SU","General, Plastic Surgery","1","For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":22,"device_class":8,"implant_flag":23,"product_code":6,"review_panel":10,"gmp_exempt_flag":24,"third_party_flag":24,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":22,"life_sustain_support_flag":24,"medical_specialty_description":11,"summary_malfunction_reporting":25},{"k_number":18},[19,20,21],"K001789","K955364","K010936","","Y","N","Eligible","2026-08-18T05:52:52.082407+00:00","2026-08-18T22:05:38.961415+00:00",0,null,3,7,[],[34,43,52,60,68,76,84,92,100,108],{"medical_device_id":35,"generic_name":36,"class_classification":37,"jmdn_code":38,"name_similarity":39,"definition_similarity":40,"vector_similarity":41,"score":42},519,"非吸収性ステープルライン補強材料","Ⅲ","70435000",0.625,0.150943,0.819983,0.0327869,{"medical_device_id":44,"generic_name":45,"class_classification":46,"jmdn_code":47,"name_similarity":48,"definition_similarity":49,"vector_similarity":50,"score":51},170,"手術用吸収性メッシュ","Ⅳ","16048004",0.471698,0.0884956,0.75216,0.031754,{"medical_device_id":53,"generic_name":54,"class_classification":46,"jmdn_code":55,"name_similarity":56,"definition_similarity":57,"vector_similarity":58,"score":59},174,"吸収性組織補強材","70434000",0.402985,0.156682,0.757407,0.031746,{"medical_device_id":61,"generic_name":62,"class_classification":37,"jmdn_code":63,"name_similarity":64,"definition_similarity":65,"vector_similarity":66,"score":67},514,"手術用メッシュ","16048003",0.264151,0.13,0.740907,0.0294372,{"medical_device_id":69,"generic_name":70,"class_classification":37,"jmdn_code":71,"name_similarity":72,"definition_similarity":73,"vector_similarity":74,"score":75},515,"非吸収性人工靭帯","35717003",0.294118,0.125654,0.688937,0.0288981,{"medical_device_id":77,"generic_name":78,"class_classification":37,"jmdn_code":79,"name_similarity":80,"definition_similarity":81,"vector_similarity":82,"score":83},1130,"縫合部補強材","70435013",0.26087,0.110465,0.73932,0.0288143,{"medical_device_id":85,"generic_name":86,"class_classification":37,"jmdn_code":87,"name_similarity":88,"definition_similarity":89,"vector_similarity":90,"score":91},530,"非吸収性骨再生用材料","70437103",0.27027,0.136364,0.698103,0.0285948,{"medical_device_id":93,"generic_name":94,"class_classification":46,"jmdn_code":95,"name_similarity":96,"definition_similarity":97,"vector_similarity":98,"score":99},230,"吸収性体内固定用ステープル","16103004",0.257143,0.115942,0.738361,0.0284045,{"medical_device_id":101,"generic_name":102,"class_classification":37,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":107},498,"非吸収性縫合糸セット","70425000",0.278689,0.130802,0.687059,0.0283094,{"medical_device_id":109,"generic_name":110,"class_classification":46,"jmdn_code":111,"name_similarity":112,"definition_similarity":113,"vector_similarity":114,"score":115},168,"吸収性体内固定用組織ステープル","35615004",0.233766,0.138095,0.748756,0.0278846,[117,121,125,129,133,137,141,145,149,153,157,160,164,168,172,175,179,182,186,190,193,197,200,203,206,210,213,216,220,223,226,229,232,235,238,241,244,247,250,253,256,259],{"product_code":118,"device_name":119,"device_class":8,"k510_count":120},"FTL","Mesh, Surgical, Polymeric",336,{"product_code":122,"device_name":123,"device_class":8,"k510_count":124},"FTM","Mesh, Surgical",163,{"product_code":126,"device_name":127,"device_class":8,"k510_count":128},"OTN","Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator",65,{"product_code":130,"device_name":131,"device_class":8,"k510_count":132},"JDK","Prosthesis, Hip, Cement Restrictor",54,{"product_code":134,"device_name":135,"device_class":8,"k510_count":136},"LZN","Cement Obturator",37,{"product_code":138,"device_name":139,"device_class":8,"k510_count":140},"OTO","Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed",23,{"product_code":142,"device_name":143,"device_class":8,"k510_count":144},"PAH","Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling",20,{"product_code":146,"device_name":147,"device_class":8,"k510_count":148},"OWY","Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon",14,{"product_code":150,"device_name":151,"device_class":8,"k510_count":152},"OOD","Surgical Film",13,{"product_code":154,"device_name":155,"device_class":8,"k510_count":156},"EZX","Mesh, Surgical, Metal",12,{"product_code":158,"device_name":159,"device_class":8,"k510_count":156},"OTM","Mesh, Surgical, For Stress Urinary Incontinence, Male",{"product_code":161,"device_name":162,"device_class":8,"k510_count":163},"OWT","Mesh, Surgical, Absorbable, Abdominal Hernia",11,{"product_code":165,"device_name":166,"device_class":8,"k510_count":167},"OWW","Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon",10,{"product_code":169,"device_name":170,"device_class":8,"k510_count":171},"OXC","Mesh, Surgical, Absorbable, Staple Line Reinforcement",9,{"product_code":173,"device_name":174,"device_class":8,"k510_count":171},"PAG","Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator",{"product_code":176,"device_name":177,"device_class":8,"k510_count":178},"OXF","Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery",8,{"product_code":180,"device_name":181,"device_class":8,"k510_count":31},"JDJ","Mesh, Surgical, Acetabular, Hip, Prosthesis",{"product_code":183,"device_name":184,"device_class":8,"k510_count":185},"ORQ","Mesh, Surgical, Deployer",6,{"product_code":187,"device_name":188,"device_class":8,"k510_count":189},"OWX","Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon",5,{"product_code":191,"device_name":192,"device_class":8,"k510_count":189},"OXH","Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery",{"product_code":194,"device_name":195,"device_class":8,"k510_count":196},"OXE","Mesh, Surgical, Collagen, Staple Line Reinforcement",4,{"product_code":198,"device_name":199,"device_class":8,"k510_count":196},"QUW","Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament",{"product_code":201,"device_name":202,"device_class":8,"k510_count":30},"OLC","Scaffold, Partial Medial Meniscal Defects Extending Into The Red\u002FWhite Zone, Resorbable Bovine Collagen",{"product_code":204,"device_name":205,"device_class":8,"k510_count":30},"PIJ","Collagen Surgical Mesh Containing Drugs",{"product_code":207,"device_name":208,"device_class":8,"k510_count":209},"OXJ","Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects",2,{"product_code":211,"device_name":212,"device_class":8,"k510_count":209},"OXK","Mesh, Surgical, Collagen, Large Abdominal Wall Defects",{"product_code":214,"device_name":215,"device_class":8,"k510_count":209},"PAJ","Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed",{"product_code":217,"device_name":218,"device_class":8,"k510_count":219},"MCA","Tape, Surgical, Internal",1,{"product_code":221,"device_name":222,"device_class":8,"k510_count":219},"OQL","Mesh, Surgical, Deployment Balloon",{"product_code":224,"device_name":225,"device_class":8,"k510_count":219},"OWR","Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery",{"product_code":227,"device_name":228,"device_class":8,"k510_count":219},"OWV","Mesh, Surgical, Collagen, Diaphragmatic Hernia",{"product_code":230,"device_name":231,"device_class":8,"k510_count":219},"OXN","Mesh, Surgical, Collagen, Fistula",{"product_code":233,"device_name":234,"device_class":8,"k510_count":219},"QWJ","Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament",{"product_code":236,"device_name":237,"device_class":8,"k510_count":28},"OWS","Mesh, Surgical, Collagen, Plastics, Facial Implants",{"product_code":239,"device_name":240,"device_class":8,"k510_count":28},"OWU","Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia",{"product_code":242,"device_name":243,"device_class":8,"k510_count":28},"OWZ","Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction",{"product_code":245,"device_name":246,"device_class":8,"k510_count":28},"OXA","Mesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction",{"product_code":248,"device_name":249,"device_class":8,"k510_count":28},"OXB","Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction",{"product_code":251,"device_name":252,"device_class":8,"k510_count":28},"OXG","Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery",{"product_code":254,"device_name":255,"device_class":8,"k510_count":28},"OXI","Mesh, Surgical, Absorbable, Large Abdominal Wall Defects",{"product_code":257,"device_name":258,"device_class":8,"k510_count":28},"OXL","Mesh, Surgical, Absorbable, Organ Support",{"product_code":260,"device_name":261,"device_class":8,"k510_count":28},"OXM","Mesh, Surgical, Absorbable, Fistula",{"510k":263,"classification":264,"enforcement":265,"event":266,"pma":267,"warning_letter":268},"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","2026-08-20T03:28:02.95+00:00",{"items":270,"total":28},[],{"items":272,"total":30},[273,280,283],{"k_number":21,"device_name":274,"applicant":275,"decision_date":276,"clearance_type":277,"decision_code":278,"statement_or_summary":279},"MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL","W. L. Gore & Associates, Inc.","2001-05-21","Traditional","SESE","Summary",{"k_number":19,"device_name":281,"applicant":275,"decision_date":282,"clearance_type":277,"decision_code":278,"statement_or_summary":279},"SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL","2000-07-06",{"k_number":20,"device_name":281,"applicant":275,"decision_date":284,"clearance_type":277,"decision_code":278,"statement_or_summary":279},"1996-02-01",{"items":286,"total":28},[]]