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
+5K242187BioBrace®Conmed Corporation20241—
+5K241906BioBrace® Reinforced ImplantConmed Corporation20243—
+5K232204ReyaGel (RG03 - MTP gel 3mL)Fettech20240—
+5K231325Corplex P / Theracor P / Allacor PStimlabs, LLC20243—
+5K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+5K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+5K211197Disposable Endoscopic Cutter Stapler and CartridgeChangzhou Waston Medical Appliance Co., Ltd.20230—
+5K222641Signia™ Small Diameter Reloads Including Regular (Round) Tip VersionCovidien202211
+5K221006GIA Stapler with Tri-Staple TechnologyCovidien20221—
+5K211132ARISTE AB MeshAriste Medical, LLC20220—
+5K211811Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers…Wuxi Beien Surgery Device Co., Ltd.20220—
+5K210331CardiaMend Pericardial and Epicardial Reconstruction MatrixHelios Cardio, Inc.20210—
+5K202425SurgiLattice scaffoldTepha, Inc.20210—
+5K210909easyEndo Lite Linear Cutting Stapler and Loading Unit for Single UseEzisurg Medical Co., Ltd.20210—
+5K200320Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular…M/s. Meril Endo Surgery Private Limited.20210—
+5K202701GIA Stapler with Tri-Staple TechnologyCovidien20202—
+5K200413SymphonyAroa Biosurgery, Ltd.20202—
+5K201000Biodesign Staple Line ReinforcementCook Biotech Incorporated20200—
+5K190937Echelon Endopath Staple Line ReinforcementEthicon Endo-Surgery, LLC20192—
+5K190528MariGen Wound ExtraKerecis Limited20193—
+5K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+5K181330NeoMatriX Wound MatrixNextgen Biologics, Inc.20181—
+5K181940GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementW. L. Gore & Associates, Inc.20181—
+5K173223ologen Collagen MatrixAeon Astron Europe B.V.20180—
+5K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+5K172538Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20170—
+5K162348ABCcolla Collagen MatrixAcro Biomedical Co., Ltd.20171—
+5K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+5K162922GalaFORM 3DTepha, Inc.20170—
+5K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+5K162554Gentrix Surgical MatrixAcell, Inc.20162—
+5K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+5K161092GalaSHAPE 3DTepha, Inc.201611
+5K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadCardica, Inc.20160—
+5K160176Signia StaplerCovidien2016514
+5K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)2016121
+5K151083BioBridge Collagen MatrixFibralign Corporation20169—
+5K152721Cytal Wound MatrixAcell, Inc.201565
+5K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+5K142326HP Tissue MatrixLifecell Corporation201411—
+5K141053Ovine Tissue Matrix (Otm)TELA Bio, Inc.20142—
+5K142070Fortiva Porcine Dermis, Tutoplast Porcine DermisRti Surgical, Inc.20140—
+5K140118Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue CartridgeCardica, Inc.201412
+5K140170Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White CartridgeCardica, Inc.201412
+5K133762Endo Gia (TM) Extra Long AdapterCovidien, LLC20140—
+5K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—
+5K132493Endo Gia Radial Reload with Tri-Staple TechnologyCovidien, LLC201301
+5K131658Gore Seamguard ReinforcementW. L. Gore & Associates, Inc.20131—
+5K130817LTN - Laparoscopic Surgical MeshLifecell Corp.20130—
+5K123318Idrive Ultra Powered Handle and Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20120—
+5K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+5K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+5K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+5K112567Biomerix AssureBiomerix Corporation20110—
+5K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+5K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+5K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…AtriCure, Inc.201018—
+5K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+5K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp.20093—
+5K083898SurgimendTei Biosciences, Inc.200993
+5K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC200864
+5K081327RelimeshHerniamesh S.R.L.20080—
+5K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+5K053200Gore Seamguard Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.200511
+5K053202Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW.L. Gore & Associates20050—
+6K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+6K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+6K253204CatalyzeBioTissue Holdings, Inc.20260—
+6K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+6K260317Artelon Convenience KitsInternational Life Sciences20260—
+6K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+6K252673LacertaMatrixLacerta Life Science20251—
+6K253339TheracorStimlabs, LLC20250—
+6K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+6K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+6K250598Endoform Reconstructive Template - PLGAAroa Biosurgery, Ltd.20250—
+6K250395BioBrace ® RC Delivery SystemConmed Corporation20250—
+6K233378ABCcolla® Collagen ADM ScaffoldAcro Biomedical Co., Ltd.20240—
+6K242828Corplex P/ Theracor P/ Allacor PStimlabs, LLC20240—
+6K241080Kerecis Parvus (50207)Kerecis Limited20241—
+6K241724Cytal® Wound Matrix; Cytal® Burn MatrixAcell, Inc.20240—
+6K231934GIA™ Stapler with Tri-Staple™ TechnologyCovidien20230—
+6K231603Standard Staple-Line Reinforcement (SSLR23)Standard Bariatrics, Inc.20230—
+6K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+6K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+6K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+6K222189SiOxD Wound MatrixSioxmed, LLC20222—
+6K221343ECHELON ENDOPATH Staple Line ReinforcementEthicon Endo-Surgery, LLC20221—
+6K213231Kerecis SiliconeKerecis Limited20221—
+6K213607Geistlich Wound Matrix PLUSGeistlich Pharma AG20220—
+6K210024NeoMatriX Wound MatrixNextgen Biologics, Inc.20210—
+6K202864Tri-Staple 2.0 ReloadsCovidien20201—
+6K193583Restrata®Acera Surgical, Inc.202011
+6K201672Signia Stapler (with new software)Covidien20200—
+6K192725Cytal Wound Matrix 3-LayerAcell, Inc.20191—
+6K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+6K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc.20190—
+6K180776Cytal Wound ParticulateAcell, Inc.20180—
+6K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc.201702
+6K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)201702