510(k) Report

Devices descending from K001789

210 later devices reach Seamguard Staple Line Reinforcement Material through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K132581Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple…Cardica, Inc.201431
+5K131705Endo Gia Radial Reload with Tri-Staple TechnologyCovidien, Formerly US Surgical A Divison of Tyco H20131—
+5K130547Endoform Reconstructive TemplateMesynthe, Ltd.20135—
+5K130717Endo Gia ReloadCovidien, Formerly US Surgical A Divison of Tyco H20130—
+5K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130—
+5K123356Fortiva Porcine DermisRti Biologics, Inc.20131—
+5K122781Reliamax Gastrointestinal Anastomosis and ReloadCovidien, Formerly US Surgical A Divison of Tyco H20130—
+5K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+5K121289LTM-Labaroscopic Surgical MeshLifecell Corp.20121—
+5K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20128—
+5K121474Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20121—
+5K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+5K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+5K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+5K093799Tornier Surgical MeshTornier, Inc.20102—
+5K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+5K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations20082—
+5K082176LTM-BPS Surgical MeshLifecell Corp.200814—
+5K082103LTM Wound DressingLifecell Corp.20087—
+5K080353LTM-T Surgical MeshLifecell Corp.20084—
+5K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc.20088—
+6K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+6K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+6K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+6K211197Disposable Endoscopic Cutter Stapler and CartridgeChangzhou Waston Medical Appliance Co., Ltd.20230—
+6K222641Signia™ Small Diameter Reloads Including Regular (Round) Tip VersionCovidien202211
+6K222189SiOxD Wound MatrixSioxmed, LLC20222—
+6K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+6K221006GIA Stapler with Tri-Staple TechnologyCovidien20221—
+6K211132ARISTE AB MeshAriste Medical, LLC20220—
+6K211811Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers…Wuxi Beien Surgery Device Co., Ltd.20220—
+6K202425SurgiLattice scaffoldTepha, Inc.20210—
+6K210909easyEndo Lite Linear Cutting Stapler and Loading Unit for Single UseEzisurg Medical Co., Ltd.20210—
+6K200320Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular…M/s. Meril Endo Surgery Private Limited.20210—
+6K202701GIA Stapler with Tri-Staple TechnologyCovidien20202—
+6K193583Restrata®Acera Surgical, Inc.202011
+6K201000Biodesign Staple Line ReinforcementCook Biotech Incorporated20200—
+6K192615Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)Synovis Life Technologies, Inc. (Baxter International Inc.)20191—
+6K172538Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20170—
+6K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc.20179—
+6K162922GalaFORM 3DTepha, Inc.20170—
+6K161092GalaSHAPE 3DTepha, Inc.201611
+6K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadCardica, Inc.20160—
+6K160176Signia StaplerCovidien2016514
+6K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)2016121
+6K151083BioBridge Collagen MatrixFibralign Corporation20169—
+6K142326HP Tissue MatrixLifecell Corporation201411—
+6K141053Ovine Tissue Matrix (Otm)TELA Bio, Inc.20142—
+6K142070Fortiva Porcine Dermis, Tutoplast Porcine DermisRti Surgical, Inc.20140—
+6K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+6K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+6K140118Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue CartridgeCardica, Inc.201412
+6K140170Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White CartridgeCardica, Inc.201412
+6K133762Endo Gia (TM) Extra Long AdapterCovidien, LLC20140—
+6K132343Marigen Wound DressingKerecis Limited20135—
+6K132493Endo Gia Radial Reload with Tri-Staple TechnologyCovidien, LLC201301
+6K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+6K130817LTN - Laparoscopic Surgical MeshLifecell Corp.20130—
+6K123318Idrive Ultra Powered Handle and Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20120—
+6K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+6K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+6K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+6K112567Biomerix AssureBiomerix Corporation20110—
+6K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+6K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+6K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp.20093—
+7K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+7K250598Endoform Reconstructive Template - PLGAAroa Biosurgery, Ltd.20250—
+7K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+7K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+7K232847SiOxD Wound MatrixSioxmed, LLC20231—
+7K231934GIA™ Stapler with Tri-Staple™ TechnologyCovidien20230—
+7K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+7K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+7K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+7K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter20210—
+7K202864Tri-Staple 2.0 ReloadsCovidien20201—
+7K201672Signia Stapler (with new software)Covidien20200—
+7K190528MariGen Wound ExtraKerecis Limited20193—
+7K180010AtriClip FLEX-VAtriCure, Inc.20188—
+7K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+7K170348Signia Four-Bay Smart Charger (to be used with Signia Stapler)Covidien20170—
+7K162752ARTIA Reconstructive Tissue Matrix PerforatedLifecell Corporation20170—
+7K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+7K153364Kerecis SecureMeshKerecis Limited20160—
+7K153632Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)20161—
+7K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+7K103787Medeor MatrixKensey Nash Corp.20112—
+8K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+8K260317Artelon Convenience KitsInternational Life Sciences20260—
+8K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+8K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+8K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+8K242187BioBrace®Conmed Corporation20241—
+8K241080Kerecis Parvus (50207)Kerecis Limited20241—
+8K213231Kerecis SiliconeKerecis Limited20221—
+8K181935Endoform Reconstructive Template - Non AbsorbableAroa Biosurgery, Ltd.20180—
+8K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+8K181474ArtiClip LAA Exclusion SystemAtriCure, Inc.20187—
+8K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—