Clearance Summary
HIGH SPEED CORE CUT BIOPSY GUN received FDA 510(k) clearance under submission number K905556, sponsored by Uni-Quatro Industries Canada, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1991-03-08.
- Submission: K905556
- Applicant / Sponsor: Uni-Quatro Industries Canada, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 1991-03-08
Classification & Regulation
This clearance is catalogued under FDA product code FCG and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class II device.