510(k) Report

Devices descending from K021019

49 later devices reach Cottony II, Silky II Polydek & Tevdek II Polyester Suture through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230510MyEllevateCynosure, LLC20230—
+1K153089'cottony' II TAPE, PLEDGETSTeleflexmedical, Inc.20162—
+1K153076silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX…Teleflexmedical, Inc.20164—
+1K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH20150—
+1K151758ALAR Nasal Valve StentMedtronic Xomed, Inc.20150—
+1K112683Smi Cardiovascular PachSolimas Medical, Inc.20111—
+1K101252Neotract Anchor System Model: Ref 11208Neotract, Inc.20101—
+1K100006HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon…Riverpoint Medical2010152
+1K091061Implicitguide Surgical Suture SystemImplicitcare, LLC20091—
+1K061276G-Prox Endoscopic GrasperUsgi Medical20065—
+1K061386Anchor Band Suturing System, Model SR-ABAnulex Technologies, Inc.200611—
+1K032901Stryker Mini-Mender Meniscal Repair SystemStryker Endoscopy20031—
+2K232733Mbrace CableMedacta International S.A.20240—
+2K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+2K202242HS FiberRiverpoint Medical, LLC20200—
+2K192490Tevdek II, Silky II Polydek, 'Cottony' II, NextStitchTeleflex Medical20201—
+2K193530Deklene MAXXTeleflex Medical20200—
+2K190817HS FiberRiverpoint Medical20196—
+2K173644Gazelle Polypropylene Suture and Delivery DeviceDura Tap, LLC20180—
+2K162396SILK Surgical SutureTeleflexmedical, Inc.20160—
+2K153307HS SutureTapeRiverpoint Medical20167—
+2K152795RiverLon (Nylon) SutureRiverpoint Medical20150—
+2K143473Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles…Cayenne Medical, Inc.20150—
+2K122105Smi Cardiovascular PatchSolinas Medical, Inc.20120—
+2K102931G-Cinch Suture GrasperUsgi Medical20100—
+2K102916G-Cath Tissue Anchor Delivery CatheterUsgi Medical20100—
+2K102028Neotract Anchor System Model TAS400Neotract, Inc.20100—
+2K100572Versaclose, Model VC-200-01Anulex Technologies, Inc.20107—
+2K100251G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333Usgi Medical20101—
+2K093018G-Prox Endoscopic Grasper, Model 205333Usgi Medical20091—
+2K082535Covidien Sports Surgery as Meniscal Repair DeviceSurgical Devices, A Global Business Unit Covidien20080—
+2K062307Xclose Tissue Repair System, Model SRSAnulex Technologies, Inc.20069—
+3K253024ProZip Knotless ImplantRiverpoint Medical20250—
+3K241111AMT Suture PasserApplied Medical Technology, Inc.20240—
+3K231163HS Fiber SuturesRiverpoint Medical20243—
+3K192637High Strength SutureYunyi (Beijing) Medical Device Co., Ltd.20200—
+3K111462Fixate Tissue BandAnulex Technologies, Inc.20116—
+3K103688G-Prox EZ Endoscopic GrasperUsgi Medical20110—
+3K091432Xclose Tissue Repair System, Model XC-200-01Anulex Technologies, Inc.20097—
+3K082518Dual Needle Suture Passer SystemCayenne Medical, Inc.20090—
+4K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.20260—
+4K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC20260—
+4K252201HS FiberRiverpoint Medical20250—
+4K113805Fixate Tissue BandAnulex Technologies, Inc.20123—
+4K113400Fixate Tissue BandAnulex Technologies, Inc.20114—
+4K112849Fixate Tissue BandAnulex Technologies, Inc.20115—
+5K172644Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading…Stimwave Technologies Incorporated20171—
+5K150924A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M.…Anchor Innovation Medical (A.I.M.)20152—
+6K191466SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc.20190—