Clearance Summary
STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES) received FDA 510(k) clearance under submission number K013059, sponsored by Stony Brook Surgical Innovations, 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 2001-10-22.
- Submission: K013059
- Applicant / Sponsor: Stony Brook Surgical Innovations, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4495
- Decision date: 2001-10-22
Classification & Regulation
This clearance is catalogued under FDA product code GAQ and 21 CFR 878.4495, within the General, Plastic Surgery review panel as a Class II device.