510(k) Report

Devices descending from K961810

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K260669Endoform Dermal TemplateAroa Biosurgery, Ltd.20260—
+5K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…Covidien (Part of Medtronic)20260—
+5K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+5K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+5K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+5K242113Nerve Wrap (07-DW-001-TAB)Biocircuit Technologies, Inc.20250—
+5K233533NerveTapeBiocircuit Technologies, Inc.20240—
+5K231708Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…Axogen Corporation20230—
+5K231491TA™ Stapler and Loading Unit with DST Series™ TechnologyCovidien20230—
+5K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+5K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+5K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+5K221013GIA Auto Suture Stapler with DST Series TechnologyCovidien20220—
+5K211132ARISTE AB MeshAriste Medical, LLC20220—
+5K211458Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear…Ningbo Verykind Medical Device Co., Ltd.20210—
+5K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter20210—
+5K211563Pitch-PatchsXiros, Ltd.20212—
+5K201639Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler…Beijing Biosis Healing Biolog Ical Technology Co., Ltd.20210—
+5K203267The BioBrace ImplantBiorez, Inc.20214—
+5K200502Myriad ParticlesAroa Biosurgery, Ltd.20214—
+5K201000Biodesign Staple Line ReinforcementCook Biotech Incorporated20200—
+5K200566ADAPT TissueAdmedus Regen Pty, Ltd.20200—
+5K192720GIA Stapler with Tri-Staple TechnologyCovidien20203—
+5K190884TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery ToolDatascope Corp.20190—
+5K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+5K192112FlexBand PlusInternational Life Sciences20199—
+5K191070Signia Small Diameter ReloadsCovidien201927
+5K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc.20190—
+5K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+5K181935Endoform Reconstructive Template - Non AbsorbableAroa Biosurgery, Ltd.20180—
+5K181620Endoscopic Linear Cutting Staplers and Loading Units for Single UseEzisurg (Suzhou) Medical Co., Ltd.20180—
+5K172593XCelliStem Wound PowderStemsys20181—
+5K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+5K173270Tri-Staple 2.0 Reinforced ReloadCovidien201802
+5K172960easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal…Ezisurg Medical Co., Ltd.20171—
+5K172545SERI ContourSofregen Medical, Inc.20170—
+5K162707Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient…Golden Stapler Surgical Co., Ltd.20171—
+5K171231Endoform Topical MatrixAroa Biosurgery20173—
+5K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc.201702
+5K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)201702
+5K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—
+5K170951CardioCel 3DAdmedus Regen Pty, Ltd.20170—
+5K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+5K162947Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting…Chongqing Qmi Surgical Co., Ltd.20170—
+5K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc.201701
+5K162710Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient…Tgs Medical Co., Ltd.20170—
+5K160969ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting StaplerShinemed, LLC20160—
+5K161757Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and…Victor Medical Instruments Co., Ltd.20163—
+5K163098Tri-Staple 2.0 Intelligent CartridgeCovidien, LLC20160—
+5K162579VascuCelAdmedus Regen Pty, Ltd.20161—
+5K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+5K153754MicroMatrixAcell, Inc.20160—
+5K151083BioBridge Collagen MatrixFibralign Corporation20169—
+5K142887SIS Inguinal Hernia Repair GraftCook Biotech Incorprated20150—
+5K151163Signia Loading Unit, Tri-Staple 2.0 CartridgeCovidien, LLC20151—
+5K143129easyEndo Linear Cutting Stapler and Loading Unit for Single Use (Stapler;Loading Unit)Ezisurg Medical Co., Ltd.20150—
+5K142326HP Tissue MatrixLifecell Corporation201411—
+5K142070Fortiva Porcine Dermis, Tutoplast Porcine DermisRti Surgical, Inc.20140—
+5K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+5K141394X-RepairSynthasome20140—
+5K141499X-RepairslSynthasome, Inc.20140—
+5K140533Galaflex MeshTepha, Inc.20143—
+5K140501Xenmatrix Surgical GraftC. R. Bard20140—
+5K132581Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple…Cardica, Inc.201431
+5K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—
+5K132343Marigen Wound DressingKerecis Limited20135—
+5K131705Endo Gia Radial Reload with Tri-Staple TechnologyCovidien, Formerly US Surgical A Divison of Tyco H20131—
+5K130717Endo Gia ReloadCovidien, Formerly US Surgical A Divison of Tyco H20130—
+5K130817LTN - Laparoscopic Surgical MeshLifecell Corp.20130—
+5K122781Reliamax Gastrointestinal Anastomosis and ReloadCovidien, Formerly US Surgical A Divison of Tyco H20130—
+5K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20128—
+5K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+5K121474Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20121—
+5K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+5K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+5K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+5K110581Propatch Soft Tissue Repair MatrixCryolife, Inc.20120—
+5K112567Biomerix AssureBiomerix Corporation20110—
+5K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+5K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC20111—
+5K112409Matristem Wound MatrixAcell, Inc.20117—
+5K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+5K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+5K100984Xylos Vessel GuardXylos Corporation20100—
+5K101546Endoform Dental TemplateMesynthes, Ltd.20100—
+5K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp.20093—
+5K090894Collawound Wound DressingCollamatrix Co., Inc.20092—
+5K080868Aongen Collagen MatrixAeon Astron Europe B.V.20091—
+5K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+5K082677Ams Elevate Anterior & Apical Prolapse Repair System with Intepro LiteAmerican Medical Systems, Inc.200811
+5K082387Apogee and Perigee Systems with Intepro Lite and Intexen LP, Part of the Ams; Pelvic…American Medical Systems20080—
+5K081710Apogee and Perigee Systems with PC Coated Intepro LiteAmerican Medical Systems20080—
+5K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+5K080185Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP…American Medical Systems, Inc.200811—
+5K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+5K070993Topas SystemAmerican Medical Systems, Inc.20071—
+5K060989Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.2006131
+5K061030Bioblanket Surgical MeshKensey Nash Corporation20064—
+5K043056Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.200477—
+5K032865Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2003102—