Clearance Summary
MESH GPS - LARGE, SMALL, SM, SM SMALL received FDA 510(k) clearance under submission number K092726, sponsored by Surgical Structures , Ltd.. 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 2010-03-15.
- Submission: K092726
- Applicant / Sponsor: Surgical Structures , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2010-03-15
Classification & Regulation
This clearance is catalogued under FDA product code OQL and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.