510(k) Report

Devices descending from K930738

231 later devices reach Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193530Deklene MAXXTeleflex Medical20200—
+1K153076silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX…Teleflexmedical, Inc.20164—
+1K120284Digitex Suture Delivery System, Digitexpolypropylene Suture Cartridge Size 0, with…Coloplast A/S201201
+1K070673Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureTeleflexmedical, Inc.200723—
+1K031443Lsi Solutions Suture Quick Load ProductsLsi Solutions20037—
+1K021019Cottony II, Silky II Polydek & Tevdek II Polyester SutureGenzyme Corp.2002497
+1K993415GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant…Boston Scientific, Target2000105—
+1K991139Guglielmi Detachable (GDC)Boston Scientific, Target1999138—
+1K981322Cutalon Nylon Polyamide Surgical SutureGenzyme Surgical Product (Genzyme Biosurgery)19980—
+2K230510MyEllevateCynosure, LLC20230—
+2K203120RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD…Lsi Solutions, Inc.20200—
+2K192490Tevdek II, Silky II Polydek, 'Cottony' II, NextStitchTeleflex Medical20201—
+2K191268Force Fiber SutureTeleflex Medical Incorporated20192—
+2K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Teleflex Medical Incorporated201810—
+2K172016Force Fiber Fusion SutureTeleflex Medical Incorporated20171—
+2K162396SILK Surgical SutureTeleflexmedical, Inc.20160—
+2K153089'cottony' II TAPE, PLEDGETSTeleflexmedical, Inc.20162—
+2K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH20150—
+2K151758ALAR Nasal Valve StentMedtronic Xomed, Inc.20150—
+2K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+2K131325Quattro GL Suture AnchorCayenne Medical, Inc.20130—
+2K112814CuffinkCayenne Medical, Inc.20120—
+2K112960Labralink Suture Anchor with Inserter, 2.9MM Per-Loaded with One (1) and (2) #2 Uhmwpe…Cayenne Medical, Inc.20121—
+2K112683Smi Cardiovascular PachSolimas Medical, Inc.20111—
+2K100593Suture Placement Device and Accessories, Flexible Suture Placement Device and…Lsi Solutions, Inc.20105—
+2K101252Neotract Anchor System Model: Ref 11208Neotract, Inc.20101—
+2K100006HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon…Riverpoint Medical2010152
+2K091061Implicitguide Surgical Suture SystemImplicitcare, LLC20091—
+2K061276G-Prox Endoscopic GrasperUsgi Medical20065—
+2K061386Anchor Band Suturing System, Model SR-ABAnulex Technologies, Inc.200611—
+2K042539GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree CoilBoston Scientific Corp2004862
+2K033836Hydrocoil Embolic System (Hes)MicroVention, Inc.200367—
+2K032901Stryker Mini-Mender Meniscal Repair SystemStryker Endoscopy20031—
+2K022420Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp.2002103—
+2K021494GDC Power Supply, Model GDC Power Supply: 451007-4Boston Scientific, Target200260—
+2K014041Trufill DCS Detachable Coil and Frufill DCS Syringe, Also Known as the Trufill DCS…Cordis Neurovascular20020—
+2K012145Microplex Coil SystemMicroVention, Inc.200196—
+3K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLC20260—
+3K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC20260—
+3K241111AMT Suture PasserApplied Medical Technology, Inc.20240—
+3K232733Mbrace CableMedacta International S.A.20240—
+3K222783MD Mattress Suture Placement DeviceLsi Solutions, Inc.20240—
+3K230311HyperSutureThreadstone, LLC20234—
+3K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+3K210675EasyWhipWinter Innovations, Inc.20211—
+3K202242HS FiberRiverpoint Medical, LLC20200—
+3K190817HS FiberRiverpoint Medical20196—
+3K173644Gazelle Polypropylene Suture and Delivery DeviceDura Tap, LLC20180—
+3K160529Pledgeted COR-SUTURE QUICK LOADLsi Soultions20161—
+3K153307HS SutureTapeRiverpoint Medical20167—
+3K152795RiverLon (Nylon) SutureRiverpoint Medical20150—
+3K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+3K143473Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles…Cayenne Medical, Inc.20150—
+3K141206Edwards Lifesciences Thruport Knotting SystemEdwards Lifesciences, LLC20151—
+3K122105Smi Cardiovascular PatchSolinas Medical, Inc.20120—
+3K103355GDC 360 Deteachable CoilBoston Scientific Corp2011163
+3K102931G-Cinch Suture GrasperUsgi Medical20100—
+3K102916G-Cath Tissue Anchor Delivery CatheterUsgi Medical20100—
+3K102028Neotract Anchor System Model TAS400Neotract, Inc.20100—
+3K100572Versaclose, Model VC-200-01Anulex Technologies, Inc.20107—
+3K100251G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333Usgi Medical20101—
+3K093142Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp201058—
+3K093018G-Prox Endoscopic Grasper, Model 205333Usgi Medical20091—
+3K092666Inzone Detachment System, Model M00345100940, Izds Connecting Cable, Model M00345100250Boston Scientific Corp20090—
+3K082535Covidien Sports Surgery as Meniscal Repair DeviceSurgical Devices, A Global Business Unit Covidien20080—
+3K080379Micrus Microcoil System, Deltapaq 10 Stretch ResistantMicrus Endovascular Corporation200810—
+3K070656Hydrocoil Embolic System (Hes)MicroVention, Inc.200736—
+3K063653Micrus Microcoil System, Cashmere Model SRCMicrus Endovascular Corporation200735—
+3K062307Xclose Tissue Repair System, Model SRSAnulex Technologies, Inc.20069—
+3K062036Micrus Microcoil System Presidio-18, Model PC4Micrus Endovascular Corporation2006341
+3K050954Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc.20056516
+3K050700Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp2005591
+3K041551Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc.200466—
+3K033813Micrus Modified Microcoil System, CerecyteMicrus Corp.200440—
+3K031578Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSRMicrus Corp.200391—
+3K022735Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with the Hydrolink…MicroVention, Inc.20020—
+3K020434Microplex Coil System (MCS)MicroVention, Inc.200270—
+3K021914Microplex Coil Systems (MCS)MicroVention, Inc.20021—
+4K261021EasyWhip FamilyWinter Innovations, Inc.20260—
+4K254275HyperSuture All Green Extension LineThreadstone, LLC20260—
+4K253024ProZip Knotless ImplantRiverpoint Medical20250—
+4K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+4K242201HyperSuture White/Green Extension LineThreadstone, LLC20251—
+4K241376HyperSuture All Blue Extension LineThreadstone, LLC20240—
+4K234079HyperSuture Extension LineThreadstone, LLC20240—
+4K231163HS Fiber SuturesRiverpoint Medical20243—
+4K203081RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureLsi Solutions20200—
+4K192637High Strength SutureYunyi (Beijing) Medical Device Co., Ltd.20200—
+4K172186BioWick X Implant with DriverCayenne Medical, Inc.20174—
+4K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil…MicroVention, Inc.20172—
+4K150882Edwards Suture Fastening SystemEdwards Lifesciences, LLC201501
+4K142429CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2…Codman & Shurtleff, Inc.20140—
+4K130577Azur Pushable 18 & 35 SystemMicroVention, Inc.20131—
+4K123338Barricade Embolization Coil SystemBlockade Medical201315—
+4K120850Target Detachable CoilStryker Neurovascular201201
+4K120274Deltamaxx 18 Microcoil SystemCodman and Shurtleff, Inc.20121—
+4K113412Target Detachable CoilStryker Neurovascular20111328
+4K112226Hydrocoil Embolic System (Hes)MicroVention, Inc.201121—
+4K112385Traget Detachable CoilStryker Neurovascular201115—
+4K111462Fixate Tissue BandAnulex Technologies, Inc.20116—