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ETHICON, Inc.

FDA 510(k) & PMA Approved Devices — 32 products

Total Devices32
Categories12
Latest FDA decision2026-07-28
TypeNumberDevice NameCodeDateActions
PMA N12159 Agent, absorbable hemostatic, non-collagen basedLMG2026-07-28 View
510(k) K253394 Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureGAM2026-06-25 View
PMA P880047 Barrier, absorbable, adhesionMCN2026-06-25 View
PMA P240035 Agent, absorbable hemostatic, collagen with polymeric additivesSGV2026-06-25 View
510(k) K252047 STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesNEW2026-05-18 View
510(k) K253572 STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceGAW2026-03-27 View
510(k) K253852 MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureGAM2026-02-06 View
510(k) K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceGAM2025-12-22 View
510(k) K243897 PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureNEW2025-11-12 View
510(k) K221744 STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceGAM2022-11-15 View
510(k) K212380 PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical SutureNEW2022-02-22 View
510(k) K213512 DERMABOND PRINEO Skin Closure SystemOMD2021-12-07 View
510(k) K201996 Monocryl Plus Antibacterial SutureGAM2020-12-21 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 GuideOTN2020-09-17 View
510(k) K201143 VICRYL MeshFTL2020-08-06 View
510(k) K192144 STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control DeviceNEW2020-03-25 View
510(k) K192580 STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control DeviceGAM2019-12-18 View
510(k) K191373 VICRYL MeshFTL2019-10-22 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 SutureGAM2019-06-27 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 DevicesNEW2019-01-10 View

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