FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253— 510(k) K991178

Substantially Equivalent

Richard Wolf Medical Instruments Corp.

FDA 510(k) clearance K991178 for FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253, Substantially Equivalent on 1999-06-11. Applicant: Richard Wolf Medical Instruments Corp..

Clearance details

Applicant: Richard Wolf Medical Instruments Corp.
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 1999-04-07
Decision date: 1999-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

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Adverse events under product code FGB

product code FGB

Death: 6
Injury: 552
Malfunction: 3,922
Other: 1
Total: 4,481

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.