FIEGERT ENDOTECH CYSTOSCOPE— 510(k) K970892

Substantially Equivalent

Fiegert, Inc.

FDA 510(k) clearance K970892 for FIEGERT ENDOTECH CYSTOSCOPE, Substantially Equivalent on 1997-05-05. Applicant: Fiegert, Inc..

Clearance details

Applicant: Fiegert, Inc.
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 1997-03-11
Decision date: 1997-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hollywood, FL, 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.