510(k) Report

Devices descending from K923657

414 later devices reach Supple Peri-Guard through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K163261AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded…AtriCure, Inc.20171—
+5K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—
+5K170945Biodesign Staple Line ReinforcementCook Biotech Incorporated20171—
+5K163457NeuraGen 3D Nerve Guide MatrixIntegra LifeSciences Corporation20170—
+5K162554Gentrix Surgical MatrixAcell, Inc.20162—
+5K153364Kerecis SecureMeshKerecis Limited20160—
+5K153632Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)20161—
+5K160400Miromatrix Biological MeshMiromatrix Medical, Inc.20160—
+5K153754MicroMatrixAcell, Inc.20160—
+5K152206SurgiPure XD Reconstructive Tissue MatrixTissue Regenix Group Plc20160—
+5K150668Biodesign Enterocutaneous Fistula PlugCook Biotech Incorprated20150—
+5K150712LTM-Perforated Surgical MeshLifecell Corporation20150—
+5K150996AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20150—
+5K142577PANTHER Endo Linear Cutter Staplers with Single Use Loading UnitsB.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.20152—
+5K150551GORE SEAMGUARD ReinforcementW. L. Gore & Associates, Inc.20150—
+5K141721Bovine Pericardium PatchCollafirm, LLC20140—
+5K142120Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20141—
+5K141394X-RepairSynthasome20140—
+5K141499X-RepairslSynthasome, Inc.20140—
+5K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+5K133938Endo Gia Reinforced Reload with Tri-Staple TechnologyCovidien20141—
+5K132025Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical20136—
+5K132343Marigen Wound DressingKerecis Limited20135—
+5K131107Atriclip Gillinov-Cosgrove Laa ClipAtriCure, Inc.20132—
+5K123128Seri Surgical ScaffoldAllergan20135—
+5K123356Fortiva Porcine DermisRti Biologics, Inc.20131—
+5K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.201215—
+5K121289LTM-Labaroscopic Surgical MeshLifecell Corp.20121—
+5K120258Duet TRS Reloads, Duet TRS Reloads with Tri-Staple Technology, Endo Gia Universal and…Covidien, Formerly US Surgical A Divison of Tyco H20121—
+5K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+5K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+5K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+5K111825Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…Covidien, Formerly US Surgical A Divison of Tyco H20114473
+5K112409Matristem Wound MatrixAcell, Inc.20117—
+5K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+5K111064Tigerpaw System IILaax, Inc.20111Class I
+5K103787Medeor MatrixKensey Nash Corp.20112—
+5K103263Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H201045—
+5K101546Endoform Dental TemplateMesynthes, Ltd.20100—
+5K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+5K093799Tornier Surgical MeshTornier, Inc.20102—
+5K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+5K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp.20093—
+5K090894Collawound Wound DressingCollamatrix Co., Inc.20092—
+5K090880Xylos Porous Surgical MeshXylos Corporation20090—
+5K080868Aongen Collagen MatrixAeon Astron Europe B.V.20091—
+5K090778Mta Protective SheetXylos Corporation20092—
+5K083898SurgimendTei Biosciences, Inc.200993
+5K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations20082—
+5K082176LTM-BPS Surgical MeshLifecell Corp.200814—
+5K082103LTM Wound DressingLifecell Corp.20087—
+5K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC200864
+5K081327RelimeshHerniamesh S.R.L.20080—
+5K080353LTM-T Surgical MeshLifecell Corp.20084—
+5K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc.20088—
+5K070644Gore Seamguard Staple Line Reinforcement Material for Circular StaplersW. L. Gore & Associates, Inc.20070—
+5K060984Xenform Soft Tissue Repair MatrixTei Biosciences, Inc.20060—
+5K060989Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.2006131
+5K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.200517—
+6K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+6K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+6K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…Covidien (Part of Medtronic)20260—
+6K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)Ethicon Endo-Surgery, LLC20260—
+6K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+6K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+6K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+6K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+6K242113Nerve Wrap (07-DW-001-TAB)Biocircuit Technologies, Inc.20250—
+6K242187BioBrace®Conmed Corporation20241—
+6K241906BioBrace® Reinforced ImplantConmed Corporation20243—
+6K232204ReyaGel (RG03 - MTP gel 3mL)Fettech20240—
+6K233533NerveTapeBiocircuit Technologies, Inc.20240—
+6K231325Corplex P / Theracor P / Allacor PStimlabs, LLC20243—
+6K231708Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…Axogen Corporation20230—
+6K231491TA™ Stapler and Loading Unit with DST Series™ TechnologyCovidien20230—
+6K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+6K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+6K221013GIA Auto Suture Stapler with DST Series TechnologyCovidien20220—
+6K211132ARISTE AB MeshAriste Medical, LLC20220—
+6K211458Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear…Ningbo Verykind Medical Device Co., Ltd.20210—
+6K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter20210—
+6K201639Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler…Beijing Biosis Healing Biolog Ical Technology Co., Ltd.20210—
+6K200413SymphonyAroa Biosurgery, Ltd.20202—
+6K201000Biodesign Staple Line ReinforcementCook Biotech Incorporated20200—
+6K192720GIA Stapler with Tri-Staple TechnologyCovidien20203—
+6K190884TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery ToolDatascope Corp.20190—
+6K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+6K191070Signia Small Diameter ReloadsCovidien201927
+6K190528MariGen Wound ExtraKerecis Limited20193—
+6K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc.20190—
+6K181935Endoform Reconstructive Template - Non AbsorbableAroa Biosurgery, Ltd.20180—
+6K181330NeoMatriX Wound MatrixNextgen Biologics, Inc.20181—
+6K181620Endoscopic Linear Cutting Staplers and Loading Units for Single UseEzisurg (Suzhou) Medical Co., Ltd.20180—
+6K173223ologen Collagen MatrixAeon Astron Europe B.V.20180—
+6K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+6K173270Tri-Staple 2.0 Reinforced ReloadCovidien201802
+6K172960easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal…Ezisurg Medical Co., Ltd.20171—
+6K172742AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)AtriCure, Inc.20170—
+6K172545SERI ContourSofregen Medical, Inc.20170—
+6K162707Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient…Golden Stapler Surgical Co., Ltd.20171—