Clearance Summary
SMARTSHEARS received FDA 510(k) clearance under submission number K112400, sponsored by Nuscience Consulting and Management Group, LLC. 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 2011-09-12.
- Submission: K112400
- Applicant / Sponsor: Nuscience Consulting and Management Group, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 2011-09-12
Classification & Regulation
This clearance is catalogued under FDA product code FZT and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.