Clearance Summary
ROBICSEK PROBE/RETRACTOR received FDA 510(k) clearance under submission number K910682, sponsored by Bio-Vascular, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1991-05-08.
- Submission: K910682
- Applicant / Sponsor: Bio-Vascular, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4475
- Decision date: 1991-05-08
Classification & Regulation
This clearance is catalogued under FDA product code DWP and 21 CFR 870.4475, within the Cardiovascular review panel as a Class II device.