Clearance Summary
VLOC9ABSORBABLE WOUND CLOSURE DEVICE received FDA 510(k) clearance under submission number K100257, sponsored by Surgical Devices, A Division of Tyco Healthcare. 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 2010-05-10.
- Submission: K100257
- Applicant / Sponsor: Surgical Devices, A Division of Tyco Healthcare
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4493
- Decision date: 2010-05-10
Classification & Regulation
This clearance is catalogued under FDA product code GAM and 21 CFR 878.4493, within the General, Plastic Surgery review panel as a Class II device.