Clearance Summary
AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY received FDA 510(k) clearance under submission number K101444, sponsored by Surgical Devices, A Global Business Unit Tyco. 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 2010-06-14.
- Submission: K101444
- Applicant / Sponsor: Surgical Devices, A Global Business Unit Tyco
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4750
- Decision date: 2010-06-14
Classification & Regulation
This clearance is catalogued under FDA product code GDW and 21 CFR 878.4750, within the General, Plastic Surgery review panel as a Class II device.