CORTEK CYSTOSCOPE— 510(k) K000197

Substantially Equivalent

Cortek Endoscopy, Inc.

FDA 510(k) clearance K000197 for CORTEK CYSTOSCOPE, Substantially Equivalent on 2000-03-03. Applicant: Cortek Endoscopy, Inc..

Clearance details

Applicant: Cortek Endoscopy, Inc.
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 2000-01-21
Decision date: 2000-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palatine, IL, US

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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.