Medical Device Manufacturer · US , Raritan , NJ

Ethicon, Inc.

202 submissions · 195 cleared · Since 1976
202
Total
195
Cleared
0
Denied

Ethicon, Inc. — FDA 510(k) Submissions

Ethicon, Inc. has submitted 202 FDA 510(k) premarket notifications since 1976, of which 195 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Suture, Absorbable, Synthetic, Polyglycolic Acid, Mesh, Surgical, Polymeric, Laparoscope, General & Plastic Surgery, Laparoscope, Gynecologic (and Accessories), Clip, Implantable . Use the specialty filter in the sidebar to narrow results.

202 devices
1–25 of 202
MONOCRYL? Plus Antibacterial Poliglecaprone ? 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
K253852 · GAM Suture, Absorbable,... · General & Plastic Surgery
Feb 2026 66d
STRATAFIX? Spiral PDS? Plus Knotless Tissue Control Device; STRATAFIX? Spiral MONOCRYL? Plus Knotless Tissue Control Device
K252743 · GAM Suture, Absorbable,... · General & Plastic Surgery
Dec 2025 116d
PDS? Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
K243897 · NEW Suture, Surgical,... · General & Plastic Surgery
Nov 2025 328d
STRATAFIX? Spiral MONOCRYL? Plus Knotless Tissue Control Device
K221744 · GAM Suture, Absorbable,... · General & Plastic Surgery
Nov 2022 152d
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
K212380 · NEW Suture, Surgical,... · General & Plastic Surgery
Feb 2022 204d
DERMABOND PRINEO Skin Closure System
K213512 · OMD Cutaneous Tissue Adhesive... · General & Plastic Surgery
Dec 2021 35d
Monocryl Plus Antibacterial Suture
K201996 · GAM Suture, Absorbable,... · General & Plastic Surgery
Dec 2020 154d
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
K201686 · OTN Mesh, Surgical,... · Gastroenterology & Urology
Sep 2020 87d
VICRYL Mesh
K201143 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Aug 2020 99d
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
K192144 · NEW Suture, Surgical,... · General & Plastic Surgery
Mar 2020 230d
STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device
K192580 · GAM Suture, Absorbable,... · General & Plastic Surgery
Dec 2019 90d
VICRYL Mesh
K191373 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Oct 2019 152d
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
K183183 · GAM Suture, Absorbable,... · General & Plastic Surgery
Jun 2019 220d
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
K182873 · NEW Suture, Surgical,... · General & Plastic Surgery
Jan 2019 90d
Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture
K181652 · GAM Suture, Absorbable,... · General & Plastic Surgery
Sep 2018 98d
GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System
K181151 · PWJ Instrumentation, Surgical... · General & Plastic Surgery
Aug 2018 101d
Temporary Cardiac Pacing Wire
K173923 · LDF Electrode, Pacemaker,... · Cardiovascular
Aug 2018 219d
PROLENE (Polypropylene) 3D Patch
K181268 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Jul 2018 73d
GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar
K173019 · PWJ Instrumentation, Surgical... · Gastroenterology & Urology
Jul 2018 281d
ULTRAPRO Mesh and ULTRAPRO ADVANCED
K180910 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Jul 2018 87d
GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide
K173162 · PWJ Instrumentation, Surgical... · Gastroenterology & Urology
Jun 2018 272d
PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh
K180829 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Jun 2018 90d
Surgical Stainless Steel Suture, Stainless Steel Suture
K170767 · GAQ Suture, Nonabsorbable,... · General & Plastic Surgery
Nov 2017 232d
PROLENE Soft Polypropylene Mesh
K172089 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Oct 2017 86d
PROLENE Soft Polypropylene Mesh
K163152 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Mar 2017 121d

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