RIWO SYSTEM TRAYS— 510(k) K012309

Substantially Equivalent

Richard Wolf Medical Instruments Corp.

FDA 510(k) clearance K012309 for RIWO SYSTEM TRAYS, Substantially Equivalent on 2001-10-19. Applicant: Richard Wolf Medical Instruments Corp..

Clearance details

Applicant: Richard Wolf Medical Instruments Corp.
Product code: Code FEB
Advisory panel: Gastroenterology, Urology
Date received: 2001-07-23
Decision date: 2001-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FEB

product code FEB

Malfunction: 3,879
Total: 3,879

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.