510(k) Report

Devices descending from K961811

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K060888Acell Powder Wound DressingAcell, Inc.20065—
+4K043259Bioblanket Surgical MeshKensey Nash Corp.200510—
+4K051766OrthomendTei Biosciences, Inc.200535—
+4K042809CuffpatchOrganogenesis, Inc.200472—
+4K040621Acell Ubm Surgical MeshAcell, Inc.20045—
+4K030782Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2003143—
+4K023328Reinforced Absorbable Synthetic Surgical MeshCenter For Biomaterials and Advanced Technologies20020—
+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—
+5K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+5K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+5K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+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—
+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—
+5K200566ADAPT TissueAdmedus Regen Pty, Ltd.20200—
+5K192720GIA Stapler with Tri-Staple TechnologyCovidien20203—
+5K190884TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery ToolDatascope Corp.20190—
+5K192112FlexBand PlusInternational Life Sciences20199—
+5K191070Signia Small Diameter ReloadsCovidien201927
+5K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20190—
+5K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+5K181038CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single…Cormatrix Cardiovascular, Inc.20181—
+5K181620Endoscopic Linear Cutting Staplers and Loading Units for Single UseEzisurg (Suzhou) Medical Co., Ltd.20180—
+5K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+5K172593XCelliStem Wound PowderStemsys20181—
+5K173270Tri-Staple 2.0 Reinforced ReloadCovidien201802
+5K172960easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal…Ezisurg Medical Co., Ltd.20171—
+5K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+5K172937Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20170—
+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—
+5K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—
+5K170945Biodesign Staple Line ReinforcementCook Biotech Incorporated20171—
+5K170951CardioCel 3DAdmedus Regen Pty, Ltd.20170—
+5K162947Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting…Chongqing Qmi Surgical Co., Ltd.20170—
+5K162710Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient…Tgs Medical Co., Ltd.20170—
+5K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)Curaseal, Inc.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—
+5K153754MicroMatrixAcell, Inc.20160—
+5K152206SurgiPure XD Reconstructive Tissue MatrixTissue Regenix Group Plc20160—
+5K150712LTM-Perforated Surgical MeshLifecell Corporation20150—
+5K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc.20153—
+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—
+5K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+5K141394X-RepairSynthasome20140—
+5K141499X-RepairslSynthasome, Inc.20140—
+5K140533Galaflex MeshTepha, Inc.20143—
+5K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+5K132581Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple…Cardica, Inc.201431
+5K132025Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical20136—
+5K132343Marigen Wound DressingKerecis Limited20135—
+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—
+5K123356Fortiva Porcine DermisRti Biologics, Inc.20131—
+5K122781Reliamax Gastrointestinal Anastomosis and ReloadCovidien, Formerly US Surgical A Divison of Tyco H20130—
+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—
+5K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+5K110581Propatch Soft Tissue Repair MatrixCryolife, Inc.20120—
+5K112409Matristem Wound MatrixAcell, Inc.20117—
+5K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+5K103787Medeor MatrixKensey Nash Corp.20112—
+5K100984Xylos Vessel GuardXylos Corporation20100—
+5K101546Endoform Dental TemplateMesynthes, Ltd.20100—
+5K093799Tornier Surgical MeshTornier, Inc.20102—
+5K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+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—
+5K082176LTM-BPS Surgical MeshLifecell Corp.200814—
+5K082103LTM Wound DressingLifecell Corp.20087—
+5K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+5K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+5K080353LTM-T Surgical MeshLifecell Corp.20084—
+5K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc.2007174
+5K070625Pelvimesh / Hermesh 7Marketing Solutions, 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—
+5K041140Acell Ubm Surgical Mesh ML and MlplusAcell, Inc.20044—
+5K032865Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2003102—
+6K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+6K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+6K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—