Clearance Summary
SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE received FDA 510(k) clearance under submission number K082828, sponsored by Suturtek Incorporated. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2008-10-14.
- Submission: K082828
- Applicant / Sponsor: Suturtek Incorporated
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4495
- Decision date: 2008-10-14
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.