12 URETEROSCOPES/URETERO-RENOSCOPES— 510(k) K963855

Substantially Equivalent

Richard Wolf Medical Instruments Corp.

FDA 510(k) clearance K963855 for 12 URETEROSCOPES/URETERO-RENOSCOPES, Substantially Equivalent on 1997-04-03. Applicant: Richard Wolf Medical Instruments Corp..

Clearance details

Applicant: Richard Wolf Medical Instruments Corp.
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 1996-09-25
Decision date: 1997-04-03
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.