510(k) K093725— CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C

Substantially Equivalent

Canada Endoscope Corporation

Clearance details

Applicant: Canada Endoscope Corporation
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 2009-12-03
Decision date: 2010-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pickering, On, CA

Adverse events under product code FAJ

product code FAJ

Injury: 533
Malfunction: 6,705
Total: 7,238

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.