FLEXIBLE FIBERSCOPES AND ACCESSORIES— 510(k) K980401

Substantially Equivalent

Richard Wolf Medical Instruments Corp.

FDA 510(k) clearance K980401 for FLEXIBLE FIBERSCOPES AND ACCESSORIES, Substantially Equivalent on 1998-05-21. Applicant: Richard Wolf Medical Instruments Corp..

Clearance details

Applicant: Richard Wolf Medical Instruments Corp.
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 1998-02-02
Decision date: 1998-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

Download summary PDF View on FDA.gov ↗

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.