Clearance Summary
BIP-COAX-SYSTEM received FDA 510(k) clearance under submission number K915801, 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 1994-03-11.
- Submission: K915801
- 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: 1994-03-11
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.