Clearance Summary
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 received FDA 510(k) clearance under submission number K201686, sponsored by ETHICON, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2020-09-17.
- Submission: K201686
- Applicant / Sponsor: ETHICON, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2020-09-17
Classification & Regulation
This clearance is catalogued under FDA product code OTN and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.