Clearance Summary
SMITH & NEWPHEW ULTRABRAID II SUTURE received FDA 510(k) clearance under submission number K101377, sponsored by Smith & Newphew, 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 2011-04-08.
- Submission: K101377
- Applicant / Sponsor: Smith & Newphew, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5000
- Decision date: 2011-04-08
Classification & Regulation
This clearance is catalogued under FDA product code GAT and 21 CFR 878.5000, within the General, Plastic Surgery review panel as a Class II device.