510(k) Report

Devices descending from K013671

43 later devices reach L-25 Absorbable Surigcal Suture through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042141Polyglytone 6211 Synthetic Absorbable SutureTeleflex Medical200411—
+1K040477MonodermSurgical Specialties Corp200429—
+1K032586Caprosyn Absorbable SutureUnited States Surgical, A Division of Tyco Healthc200312—
+2K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Teleflex Medical Incorporated201810—
+2K052437Modified Monoderm Monofilament, Synthetic, Absorbable SutureSurgical Specialties Corp200528—
+3K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLC20260—
+3K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC20260—
+3K230311HyperSutureThreadstone, LLC20234—
+3K191268Force Fiber SutureTeleflex Medical Incorporated20192—
+3K141558Quill Monoderm Knotless Tissue-Closure DeviceSurgical Specialties Corp20140—
+3K140227Monoderm Surgical SutureSurgical Specialties Corp20140—
+3K072028Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp200726—
+4K254275HyperSuture All Green Extension LineThreadstone, LLC20260—
+4K242201HyperSuture White/Green Extension LineThreadstone, LLC20251—
+4K241376HyperSuture All Blue Extension LineThreadstone, LLC20240—
+4K234079HyperSuture Extension LineThreadstone, LLC20240—
+4K210675EasyWhipWinter Innovations, Inc.20211—
+4K192580STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc.201901
+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
+4K100257VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare2010241
+5K261021EasyWhip FamilyWinter Innovations, Inc.20260—
+5K173874StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOOrigami Surgical, LLC20183—
+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—
+5K130078Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech20135—
+5K123836Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech201211—
+6K2322461) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2)…M/s. Meril Endo Surgery Private Limited.20241—
+6K212810MONOFIX PGCL, knotless wound closure deviceSamyang Holdings Corp., Ltd.20220—
+6K202950StitchKit COMBOOrigami Surgical20212—
+6K182873STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus…ETHICON, Inc.201975
+6K151112Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignAngiotech20151—
+6K131224Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical Suture, Quill…Surgical Specialties Corp. Dba Angiotech20132—
+7K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.20260—
+7K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™…ETHICON, Inc.20260—
+7K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™…ETHICON, Inc.20250—
+7K252644PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™…M/s. Meril Endo Surgery Private Limited.20250—
+7K233355Cypris eXact Suturing SystemCypris Medical20240—
+7K221744STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.20222—
+7K211178DURAMESH Mesh SutureMsi20220—
+7K211792StitchKitOrigami Surgical Inc .20211—
+7K192144STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc.202011
+8K221527StitchKitOrigami Surgical Inc .20230—