510(k) Report

Devices descending from K983162

336 later devices reach Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K042809CuffpatchOrganogenesis, Inc.200472—
+3K040621Acell Ubm Surgical MeshAcell, Inc.20045—
+3K030782Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2003143—
+3K023328Reinforced Absorbable Synthetic Surgical MeshCenter For Biomaterials and Advanced Technologies20020—
+4K260669Endoform Dermal TemplateAroa Biosurgery, Ltd.20260—
+4K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…Covidien (Part of Medtronic)20260—
+4K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+4K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+4K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+4K231491TA™ Stapler and Loading Unit with DST Series™ TechnologyCovidien20230—
+4K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+4K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+4K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+4K221013GIA Auto Suture Stapler with DST Series TechnologyCovidien20220—
+4K211458Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear…Ningbo Verykind Medical Device Co., Ltd.20210—
+4K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter20210—
+4K211563Pitch-PatchsXiros, Ltd.20212—
+4K201639Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler…Beijing Biosis Healing Biolog Ical Technology Co., Ltd.20210—
+4K203267The BioBrace ImplantBiorez, Inc.20214—
+4K200502Myriad ParticlesAroa Biosurgery, Ltd.20214—
+4K200566ADAPT TissueAdmedus Regen Pty, Ltd.20200—
+4K192720GIA Stapler with Tri-Staple TechnologyCovidien20203—
+4K190884TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery ToolDatascope Corp.20190—
+4K192112FlexBand PlusInternational Life Sciences20199—
+4K191070Signia Small Diameter ReloadsCovidien201927
+4K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20190—
+4K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+4K181038CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single…Cormatrix Cardiovascular, Inc.20181—
+4K181620Endoscopic Linear Cutting Staplers and Loading Units for Single UseEzisurg (Suzhou) Medical Co., Ltd.20180—
+4K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+4K172593XCelliStem Wound PowderStemsys20181—
+4K173270Tri-Staple 2.0 Reinforced ReloadCovidien201802
+4K172960easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal…Ezisurg Medical Co., Ltd.20171—
+4K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+4K172937Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20170—
+4K172545SERI ContourSofregen Medical, Inc.20170—
+4K162707Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient…Golden Stapler Surgical Co., Ltd.20171—
+4K171231Endoform Topical MatrixAroa Biosurgery20173—
+4K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—
+4K170945Biodesign Staple Line ReinforcementCook Biotech Incorporated20171—
+4K170951CardioCel 3DAdmedus Regen Pty, Ltd.20170—
+4K162947Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting…Chongqing Qmi Surgical Co., Ltd.20170—
+4K162710Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient…Tgs Medical Co., Ltd.20170—
+4K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)Curaseal, Inc.20170—
+4K160969ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting StaplerShinemed, LLC20160—
+4K161757Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and…Victor Medical Instruments Co., Ltd.20163—
+4K163098Tri-Staple 2.0 Intelligent CartridgeCovidien, LLC20160—
+4K162579VascuCelAdmedus Regen Pty, Ltd.20161—
+4K153754MicroMatrixAcell, Inc.20160—
+4K152206SurgiPure XD Reconstructive Tissue MatrixTissue Regenix Group Plc20160—
+4K150712LTM-Perforated Surgical MeshLifecell Corporation20150—
+4K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc.20153—
+4K151163Signia Loading Unit, Tri-Staple 2.0 CartridgeCovidien, LLC20151—
+4K143129easyEndo Linear Cutting Stapler and Loading Unit for Single Use (Stapler;Loading Unit)Ezisurg Medical Co., Ltd.20150—
+4K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+4K141394X-RepairSynthasome20140—
+4K141499X-RepairslSynthasome, Inc.20140—
+4K140533Galaflex MeshTepha, Inc.20143—
+4K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+4K132581Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple…Cardica, Inc.201431
+4K132025Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical20136—
+4K132343Marigen Wound DressingKerecis Limited20135—
+4K131705Endo Gia Radial Reload with Tri-Staple TechnologyCovidien, Formerly US Surgical A Divison of Tyco H20131—
+4K130547Endoform Reconstructive TemplateMesynthe, Ltd.20135—
+4K130717Endo Gia ReloadCovidien, Formerly US Surgical A Divison of Tyco H20130—
+4K123356Fortiva Porcine DermisRti Biologics, Inc.20131—
+4K122781Reliamax Gastrointestinal Anastomosis and ReloadCovidien, Formerly US Surgical A Divison of Tyco H20130—
+4K121289LTM-Labaroscopic Surgical MeshLifecell Corp.20121—
+4K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20128—
+4K121474Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20121—
+4K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+4K110581Propatch Soft Tissue Repair MatrixCryolife, Inc.20120—
+4K112409Matristem Wound MatrixAcell, Inc.20117—
+4K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+4K103787Medeor MatrixKensey Nash Corp.20112—
+4K100984Xylos Vessel GuardXylos Corporation20100—
+4K101546Endoform Dental TemplateMesynthes, Ltd.20100—
+4K093799Tornier Surgical MeshTornier, Inc.20102—
+4K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+4K090894Collawound Wound DressingCollamatrix Co., Inc.20092—
+4K080868Aongen Collagen MatrixAeon Astron Europe B.V.20091—
+4K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+4K082176LTM-BPS Surgical MeshLifecell Corp.200814—
+4K082103LTM Wound DressingLifecell Corp.20087—
+4K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+4K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+4K080353LTM-T Surgical MeshLifecell Corp.20084—
+4K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc.2007174
+4K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+4K060989Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.2006131
+4K061030Bioblanket Surgical MeshKensey Nash Corporation20064—
+4K043056Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.200477—
+4K041140Acell Ubm Surgical Mesh ML and MlplusAcell, Inc.20044—
+4K032865Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2003102—
+5K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+5K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+5K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+5K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+5K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+5K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—