510(k) Report

Devices descending from K022269

108 later devices reach Coated Vicryl* (Polyglactin 910) Suture through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170166CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing)…Cpt Sutures Co., Ltd.20170—
+1K153611Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND…Ethicon, LLC20160—
+1K142822PLIASURE Polyglycolide Synthetic Absorbable SutureETHICON, Inc.20150—
+1K132348Tephaflex Braided SutureTepha, Inc.20130—
+1K122734Aesculap Novosyn Absorbable SutureAesculap, Inc.20125—
+1K120556Vilet Vilet QuickRiverpoint Medical2012241
+1K072859Atramat PGLA90 Poly (Glycolide-CO-L-Lactide) Surgical SuturesInternacional Farmaceutica, S.A. DE C.V.20081—
+1K062366Optime, Sinusorb PgaPeters Surgical20061—
+1K060367TenoligFournitures Hospitalieres Industrie20063—
+1K024117Insorb Absorbable Staples, Model SP-B20Incisive Surgical, Inc.2003681
+1K030594I-125 Rapid Strand, Model 7000Amersham Health200317—
+2K263073Fast Absorbing PGLARiverpoint Medical, LLC20260—
+2K252820PGLA90 Poly (glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly…Internacional Farmacéutica S.A DE C.V20250—
+2K170661Novosyn Quick Absorbable SutureAesculap, Inc.20170—
+2K143584Pga Resorba, Pga Resoquick, GlycolonResorba Medical GmbH20150—
+2K123940Demequicktm (Rapid Absorbable) Synthetic Surgical SutureDemetech Corp.20140—
+2K131563Subq IT! Bioabsorbable Skin Closure SystemOpus Ksd, Inc.20140—
+2K130735Synthetic Absorbable SutureFoosin Medical Supplies Inc., Ltd.20143—
+2K080974TLS Fixation SystemFournitures Hospitalieres Industrie20082—
+2K063177Rapid Strand RXOncura, Inc.200611
+2K062384Cesium-131 Strand, Strand Preload, Preload, S-CartridgeIsoray, Inc.20067—
+2K053595Curay Custom Seed ArrayBiolucent, Inc.20060—
+2K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc.200564—
+2K040339Brachytherapy Strand DeviceBebig Isotopen-Und Medizintechnik GmbH200414—
+2K033602Insorb Absorbable Staple, Model SP-B20Incisive Surgical, Inc.200321
+3K180027ACCUSYTE 3D Fiducial MarkerRadiation Products, LLC20180—
+3K173874StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOOrigami Surgical, LLC20183—
+3K173043Holycon Synthetic Absorbable SuturesNantong Holycon Medical Devices Co., Ltd.20170—
+3K161629CrylrexSm Eng Co., Ltd.20170—
+3K133420Tranquill Barbed DeviceSurgical Specialties Corp. Dba Angiotech20136—
+3K120740Cols® Fixation SystemFournitures Hospitalieres Industrie20130—
+3K122764Rapid Strand RXMedi-Physics, Inc.20120—
+3K113210Advantage-Strand/Advantage-Load Brachytherapy KitIsoaid, LLC20121—
+3K120827Quill Pdo Knotless Tissue-Closure Device (Polydixanone)Angiotech201213—
+3K113744Quill Pdo Knotless Tissue-Closure Device (Polydioxanone)Angiotech201225—
+3K113591Cols PeekFournitures Hospitalieres Industrie20110—
+3K091117Advantage-Strand/ Advantage-Load Brachytherapy Kit, Model IaslbkaIsoaid, LLC20090—
+3K092458Proxcelan CS-131PRELOADED Strands, Model PL-1, Proxcelan CS-131 Preloaded Strands in 18…Isoray Medical, Inc.20091—
+3K092136Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5Isoray Medical, Inc.20094—
+3K080985Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp200829—
+3K080680Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp200830—
+3K072296Poiint of Care Stranding System, Mode 1004-00Theragenics Corp.200701
+3K071989Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialSurgical Specialties Corp200731—
+3K072028Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp200726—
+3K061784Insorb Absorbable Staple, Model 1020Incisive Surgical, Inc.200611
+3K053380Contour Thread Synthetic Absorbable Pdo Barbed SutureSurgical Specialties Corp20063—
+3K052962Optimized Barb DesignSurgical Specialties Corp20050—
+3K052373Quill Nonabsorbable Polypropylene Barbed SutureQuill Medical, Inc.200510—
+3K043596Theraload Custom Loaded Needles, Models 200 and 125.S06Theragenics Corp.20059—
+4K253879Monofix PdoSamyang Holdings Corporation20260—
+4K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™…ETHICON, Inc.20260—
+4K242818IsoSphereIsoaid, LLC20250—
+4K210871PDO Max Suture with Dual NeedlePdo Max, Inc.20210—
+4K202950StitchKit COMBOOrigami Surgical20212—
+4K202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc.20200—
+4K201139WEGO-PDO Barbed SutureFoosin Medical Supplies Inc., Ltd.20200—
+4K192144STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc.202011
+4K192580STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc.201901
+4K190264ViolaMeditime Co., Ltd.20190—
+4K172602MiracuFeeltech Co., Ltd.20184—
+4K180515GammaTileIsoray Medical, Inc.20183—
+4K171039Assut Filbloc Permanent SuturesAssut Europe S.P.A.20171—
+4K160705Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,Y. Jacobs Medical, Inc.20160—
+4K143413J+PRAS YOUNG'S ThreadY. Jacobs Medical, Inc.20150—
+4K150670STRATAFIX Spiral PDS Plus Knotless Tissue Control DeviceETHICON, Inc.20158—
+4K141558Quill Monoderm Knotless Tissue-Closure DeviceSurgical Specialties Corp20140—
+4K132268Quill Pdo Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corporation Dba Angiotech20130—
+4K130191MINTHans Biomed Corporation20135—
+4K131224Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical Suture, Quill…Surgical Specialties Corp. Dba Angiotech20132—
+4K130078Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech20135—
+4K123877Quill Pdo Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech201311—
+4K123409Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech201218—
+4K122898Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech2012191
+4K113800Quill Quadrahelix Tissue-Closure DeviceAngiotech20123—
+4K113004PDS (TM) Barbed SuturesETHICON, Inc.201111
+4K100257VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare2010241
+4K093408V-Loc 180 Absorbable Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare200901
+4K073614WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc.20082—
+4K052900Quill Nonabsorbable Nylon Barbed SutureQuill Medical, Inc.20050—
+5K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™…ETHICON, Inc.20250—
+5K250107V-soft Line™ Barbed Surgical Suture (Various)Feeltech Co., Ltd.20250—
+5K240389Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread…Hyundae Meditech Co., Ltd.20241—
+5K233355Cypris eXact Suturing SystemCypris Medical20240—
+5K211178DURAMESH Mesh SutureMsi20220—
+5K211792StitchKitOrigami Surgical Inc .20211—
+5K192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC20200—
+5K200392RexsinSm Eng Co., Ltd.20200—
+5K191361DemeDIOX Barbed Absorbable Surgical SutureDemetech Corporation20190—
+5K190245PDS Barbed Suture, PDO MAXX ThreadsPdo Max, Inc.20190—
+5K190296GammaTileGt Medical Technologies20192—
+5K182873STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus…ETHICON, Inc.201975
+5K173779Rexmono, PdrexSm Eng Co., Ltd.20180—
+5K162366Omega VLOv World Co., Ltd.20180—
+5K160761DW-1CDongwon Medical Co., Ltd.20161—
+5K151112Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignAngiotech20151—
+5K151200STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus…ETHICON, Inc.201581
+5K141778Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corporation201410—
+5K123836Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech201211—
+6K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.20260—
+6K242571Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150…Hyundae Meditech Co., Ltd.20240—