Ethicon, Inc. - FDA 510(k) Cleared Devices
Recent clearances: STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices, STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device, MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
204
Total
197
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ethicon, Inc. Gastroenterology & Urology ✕
10 devices
Cleared
Sep 17, 2020
GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE...
Gastroenterology & Urology
87d
Cleared
Jul 06, 2018
GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide,...
Gastroenterology & Urology
281d
Cleared
Jun 28, 2018
GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable...
Gastroenterology & Urology
272d
Cleared
Aug 23, 2013
GYNECARE TVT EXACT CONTINENCE SYSTEM
Gastroenterology & Urology
51d
Cleared
Jul 01, 2010
GYNECARE TVT ABBREVO CONTINENCE SYSTEM
Gastroenterology & Urology
87d
Cleared
Mar 16, 2010
GYNECARE TVT EXACT CONTINENCE SYSTEM
Gastroenterology & Urology
25d
Cleared
Nov 28, 2005
GYNECARE TVT SECUR SYSTEM
Gastroenterology & Urology
88d
Cleared
Dec 08, 2003
GYNECARE TVT OBTURATOR SYSTEM
Gastroenterology & Urology
26d
Cleared
Jan 28, 1998
PUBOUURETHRAL SLING
Gastroenterology & Urology
90d
Cleared
Jan 03, 1994
ENDOPATH ENDOSCOPIC LINEAR CUTTER MODIFICATION
Gastroenterology & Urology
75d