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ETHICON, Inc.

FDA 510(k) & PMA Approved Devices — 30 products

Total Devices30
Categories12
Latest Approval2026-03-27
TypeNumberDevice NameCodeDate
510(k) K253572 STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device GAW 2026-03-27 View
510(k) K253852 MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture GAM 2026-02-06 View
510(k) K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device GAM 2025-12-22 View
PMA P240035 Agent, absorbable hemostatic, collagen with polymeric additives SGV 2025-12-15 View
510(k) K243897 PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture NEW 2025-11-12 View
510(k) K221744 STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device GAM 2022-11-15 View
510(k) K212380 PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture NEW 2022-02-22 View
510(k) K213512 DERMABOND PRINEO Skin Closure System OMD 2021-12-07 View
510(k) K201996 Monocryl Plus Antibacterial Suture GAM 2020-12-21 View
510(k) K201686 GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide OTN 2020-09-17 View
510(k) K201143 VICRYL Mesh FTL 2020-08-06 View
510(k) K192144 STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device NEW 2020-03-25 View
510(k) K192580 STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device GAM 2019-12-18 View
510(k) K191373 VICRYL Mesh FTL 2019-10-22 View
510(k) K183183 VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture GAM 2019-06-27 View
510(k) K182873 STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices NEW 2019-01-10 View
510(k) K181652 Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture GAM 2018-09-28 View
510(k) K181151 GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System PWJ 2018-08-10 View
510(k) K173923 Temporary Cardiac Pacing Wire LDF 2018-08-02 View
510(k) K181268 PROLENE (Polypropylene) 3D Patch FTL 2018-07-26 View
510(k) K173019 GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar PWJ 2018-07-06 View
510(k) K180910 ULTRAPRO Mesh and ULTRAPRO ADVANCED FTL 2018-07-02 View
510(k) K180829 PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh FTL 2018-06-28 View
510(k) K173162 GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide PWJ 2018-06-28 View
510(k) K170767 Surgical Stainless Steel Suture, Stainless Steel Suture GAQ 2017-11-01 View
510(k) K172089 PROLENE Soft Polypropylene Mesh FTL 2017-10-05 View
510(k) K163152 PROLENE Soft Polypropylene Mesh FTL 2017-03-11 View
PMA P880047 Barrier, absorbable, adhesion MCN 2016-10-26 View
PMA N12159 Agent, absorbable hemostatic, non-collagen based LMG 2016-10-25 View
510(k) K161726 E-Pack Procedure Kit GAM 2016-07-12 View
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