Clearance Summary
GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM received FDA 510(k) clearance under submission number K012628, sponsored by Gynecare Center. 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 2001-10-26.
- Submission: K012628
- Applicant / Sponsor: Gynecare Center
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2001-10-26
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.