BIP-COAX-SYSTEM— 510(k) K915801

Substantially Equivalent

Uni-Quatro Industries Canada, Inc.

FDA 510(k) clearance K915801 for BIP-COAX-SYSTEM, Substantially Equivalent on 1994-03-11. Applicant: Uni-Quatro Industries Canada, Inc..

Clearance details

Applicant: Uni-Quatro Industries Canada, Inc.
Product code: Code FCG
Advisory panel: Gastroenterology, Urology
Date received: 1991-12-24
Decision date: 1994-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niagara Falls, Ontario, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code FCG

product code FCG

Death: 13
Injury: 576
Malfunction: 1,966
Total: 2,555

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.