Clearance Summary
S&T SINGLE USE MICRO ANASTOMOSIS CLAMP received FDA 510(k) clearance under submission number K022754, sponsored by S & T AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2002-10-16.
- Submission: K022754
- Applicant / Sponsor: S & T AG
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4450
- Decision date: 2002-10-16
Classification & Regulation
This clearance is catalogued under FDA product code DXC and 21 CFR 870.4450, within the Cardiovascular review panel as a Class II device.