510(k) Report

Devices descending from K944110

72 later devices reach Vicryl Rapide Suture through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183004Wego-Pga RapidFoosin Medical Supplies Inc., Ltd.20190—
+1K183001Wego-Pgla RapidFoosin Medical Supplies Inc., Ltd.20190—
+1K170661Novosyn Quick Absorbable SutureAesculap, Inc.20170—
+1K060248Ultratine TransblephCoapt Systems, Inc.20060—
+1K060249Ultratine ForeheadCoapt Systems, Inc.20060—
+1K040282Atramat and Sorb-Fast Polyglycolic AcidInternacional Farmaceutica, S.A. DE C.V.20041—
+1K040339Brachytherapy Strand DeviceBebig Isotopen-Und Medizintechnik GmbH200414—
+1K031286Safil and Safil Quick Synthetic Absorbable Surgical SutureAesculap, Inc.200331
+1K014021Sharpoint Coated, Fast Absorbing Polyglycolic Acid Synthetic Suture, UndyedSurgical Specialties Corp20020—
+1K013671L-25 Absorbable Surigcal SutureUnited States Surgical, A Division of Tyco Healthc200243—
+1K980610Dexon Rapid (Dexon R)Davis & Geck, Inc.19980—
+2K233265Monotime and Optime RPeters Surgical20240—
+2K113210Advantage-Strand/Advantage-Load Brachytherapy KitIsoaid, LLC20121—
+2K091117Advantage-Strand/ Advantage-Load Brachytherapy Kit, Model IaslbkaIsoaid, LLC20090—
+2K072296Poiint of Care Stranding System, Mode 1004-00Theragenics Corp.200701
+2K063462Neatstitch Neatclose Suturing DeviceNeat Stitch, Ltd.20070—
+2K062384Cesium-131 Strand, Strand Preload, Preload, S-CartridgeIsoray, Inc.20067—
+2K061796Hepatostat Set, Model 760XVygon Corp.20061—
+2K043596Theraload Custom Loaded Needles, Models 200 and 125.S06Theragenics Corp.20059—
+2K042141Polyglytone 6211 Synthetic Absorbable SutureTeleflex Medical200411—
+2K040477MonodermSurgical Specialties Corp200429—
+2K032586Caprosyn Absorbable SutureUnited States Surgical, A Division of Tyco Healthc200312—
+3K242818IsoSphereIsoaid, LLC20250—
+3K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Teleflex Medical Incorporated201810—
+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—
+3K073493Hepatostat SetVygon Corp.20080—
+3K053595Curay Custom Seed ArrayBiolucent, Inc.20060—
+3K052437Modified Monoderm Monofilament, Synthetic, Absorbable SutureSurgical Specialties Corp200528—
+4K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLC20260—
+4K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC20260—
+4K230311HyperSutureThreadstone, LLC20234—
+4K202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc.20200—
+4K191268Force Fiber SutureTeleflex Medical Incorporated20192—
+4K180515GammaTileIsoray Medical, Inc.20183—
+4K141558Quill Monoderm Knotless Tissue-Closure DeviceSurgical Specialties Corp20140—
+4K140227Monoderm Surgical SutureSurgical Specialties Corp20140—
+4K072028Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp200726—
+5K254275HyperSuture All Green Extension LineThreadstone, LLC20260—
+5K242201HyperSuture White/Green Extension LineThreadstone, LLC20251—
+5K241376HyperSuture All Blue Extension LineThreadstone, LLC20240—
+5K234079HyperSuture Extension LineThreadstone, LLC20240—
+5K210675EasyWhipWinter Innovations, Inc.20211—
+5K192580STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc.201901
+5K190296GammaTileGt Medical Technologies20192—
+5K123409Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech201218—
+5K122898Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech2012191
+5K100257VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare2010241
+6K261021EasyWhip FamilyWinter Innovations, Inc.20260—
+6K190839GammaTileGt Medical Technologies20201—
+6K173874StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOOrigami Surgical, LLC20183—
+6K151200STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus…ETHICON, Inc.201581
+6K141778Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corporation201410—
+6K130078Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech20135—
+6K123836Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech201211—
+7K2322461) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2)…M/s. Meril Endo Surgery Private Limited.20241—
+7K221539GammaTileGt Medical Technologies20220—
+7K212810MONOFIX PGCL, knotless wound closure deviceSamyang Holdings Corp., Ltd.20220—
+7K202950StitchKit COMBOOrigami Surgical20212—
+7K182873STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus…ETHICON, Inc.201975
+7K151112Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignAngiotech20151—
+7K131224Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical Suture, Quill…Surgical Specialties Corp. Dba Angiotech20132—
+8K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.20260—
+8K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™…ETHICON, Inc.20260—
+8K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™…ETHICON, Inc.20250—
+8K252644PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™…M/s. Meril Endo Surgery Private Limited.20250—
+8K233355Cypris eXact Suturing SystemCypris Medical20240—
+8K221744STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.20222—
+8K211178DURAMESH Mesh SutureMsi20220—
+8K211792StitchKitOrigami Surgical Inc .20211—
+8K192144STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc.202011
+9K221527StitchKitOrigami Surgical Inc .20230—