Clearance Summary
GYNECARE TVT EXACT CONTINENCE SYSTEM received FDA 510(k) clearance under submission number K100485, sponsored by ETHICON, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2010-03-16.
- Submission: K100485
- Applicant / Sponsor: ETHICON, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2010-03-16
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.