510(k) Report

Devices descending from K960653

193 later devices reach Monocryl (Poliglecaprone 25) Suture, Dyed (Modified) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143584Pga Resorba, Pga Resoquick, GlycolonResorba Medical GmbH20150—
+1K130083Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable SutureDemetech Corp.20131—
+1K100461PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic GutRiverpoint Medical201051
+1K072863Atramat PGC25 Poly (Glycolide-CO-Epsilon-Caprolactone) Surgical SuturesInternacional Farmaceutica, S.A. DE C.V.20080—
+1K072229MonoswiftCp Medical200701
+1K072028Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp200726—
+1K050845Monocryl Plus Antibacterial SutureETHICON, Inc.2005251
+1K014183Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center2002145—
+2K232372Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)Peters Surgical20240—
+2K201996Monocryl Plus Antibacterial SutureETHICON, Inc.202011
+2K192580STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc.201901
+2K151200STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus…ETHICON, Inc.201581
+2K141558Quill Monoderm Knotless Tissue-Closure DeviceSurgical Specialties Corp20140—
+2K130737Synthetic Absorbable SutureFoosin Medical Supplies Inc., Ltd.20142—
+2K123409Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech201218—
+2K122898Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech2012191
+2K100257VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare2010241
+2K061037PDS Plus Antibacterial SutureETHICON, Inc.2006219
+2K030782Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2003143—
+2K023328Reinforced Absorbable Synthetic Surgical MeshCenter For Biomaterials and Advanced Technologies20020—
+3K253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic…ETHICON, Inc.20260—
+3K2322461) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2)…M/s. Meril Endo Surgery Private Limited.20241—
+3K212380PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical SutureETHICON, Inc.202221
+3K183183VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II…ETHICON, Inc.201903
+3K182873STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus…ETHICON, Inc.201975
+3K173874StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOOrigami Surgical, LLC20183—
+3K150670STRATAFIX Spiral PDS Plus Knotless Tissue Control DeviceETHICON, Inc.20158—
+3K142810WEGO-PGCL Absorbable Surgical Monofilament SutureFoosin Medical Supplies Inc., Ltd.20141—
+3K141778Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corporation201410—
+3K130078Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech20135—
+3K123836Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech201211—
+3K113004PDS (TM) Barbed SuturesETHICON, Inc.201111
+3K043056Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.200477—
+3K033671Gore Bioabsorbable MeshW. L. Gore & Associates, Inc.200339—
+3K032865Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2003102—
+4K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.20260—
+4K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™…ETHICON, Inc.20250—
+4K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.20250—
+4K251414Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)Feeltech Co., Ltd.20250—
+4K252644PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™…M/s. Meril Endo Surgery Private Limited.20250—
+4K221744STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.20222—
+4K212810MONOFIX PGCL, knotless wound closure deviceSamyang Holdings Corp., Ltd.20220—
+4K202950StitchKit COMBOOrigami Surgical20212—
+4K192144STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc.202011
+4K191361DemeDIOX Barbed Absorbable Surgical SutureDemetech Corporation20190—
+4K190937Echelon Endopath Staple Line ReinforcementEthicon Endo-Surgery, LLC20192—
+4K181940GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementW. L. Gore & Associates, Inc.20181—
+4K173143Phasix ST MeshC.R. Bard, Inc.20181—
+4K173779Rexmono, PdrexSm Eng Co., Ltd.20180—
+4K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20175—
+4K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.20153—
+4K151112Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignAngiotech20151—
+4K130997NeoveilGunze Limited20133—
+4K131658Gore Seamguard ReinforcementW. L. Gore & Associates, Inc.20131—
+4K131224Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical Suture, Quill…Surgical Specialties Corp. Dba Angiotech20132—
+4K130326Tephaflex Meltblown ConstructTepha, Inc.20130—
+4K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…AtriCure, Inc.201018—
+4K083266Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc.200912—
+4K080898Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line…Tyco Healthcare Group LP20084824
+4K071016Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200713—
+4K0709184DDOMECousin Biotech20070—
+4K053200Gore Seamguard Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.200511
+4K053202Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW.L. Gore & Associates20050—
+4K051048Surgisis Staple Line Reinforcement IICook Biotech, Inc.20053—
+4K040119Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line…Synovis Surgical Innovations200469—
+5K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™…ETHICON, Inc.20260—
+5K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+5K233355Cypris eXact Suturing SystemCypris Medical20240—
+5K231603Standard Staple-Line Reinforcement (SSLR23)Standard Bariatrics, Inc.20230—
+5K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+5K221343ECHELON ENDOPATH Staple Line ReinforcementEthicon Endo-Surgery, LLC20221—
+5K211178DURAMESH Mesh SutureMsi20220—
+5K221487NEOVEIL Staple Line ReinforcementGunze Limited20220—
+5K211792StitchKitOrigami Surgical Inc .20211—
+5K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20190—
+5K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+5K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+5K163261AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded…AtriCure, Inc.20171—
+5K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—
+5K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)Curaseal, Inc.20170—
+5K150996AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20150—
+5K142577PANTHER Endo Linear Cutter Staplers with Single Use Loading UnitsB.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.20152—
+5K150551GORE SEAMGUARD ReinforcementW. L. Gore & Associates, Inc.20150—
+5K142120Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20141—
+5K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+5K133938Endo Gia Reinforced Reload with Tri-Staple TechnologyCovidien20141—
+5K131107Atriclip Gillinov-Cosgrove Laa ClipAtriCure, Inc.20132—
+5K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.201215—
+5K120258Duet TRS Reloads, Duet TRS Reloads with Tri-Staple Technology, Endo Gia Universal and…Covidien, Formerly US Surgical A Divison of Tyco H20121—
+5K111825Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…Covidien, Formerly US Surgical A Divison of Tyco H20114473
+5K103263Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H201045—
+5K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+5K070405Modification to Surgisis SLR Staple Line ReinforcementCook Biotech, Inc.20072—
+5K070644Gore Seamguard Staple Line Reinforcement Material for Circular StaplersW. L. Gore & Associates, Inc.20070—
+5K062915Veritas Collagen MatrixSynovis Surgical Innovations2006151
+6K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…Covidien (Part of Medtronic)20260—
+6K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)Ethicon Endo-Surgery, LLC20260—
+6K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+6K231491TA™ Stapler and Loading Unit with DST Series™ TechnologyCovidien20230—
+6K221527StitchKitOrigami Surgical Inc .20230—