ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2— 510(k) K121724

Substantially Equivalent

Richard Wolf Medical Instruments Corp.

FDA 510(k) clearance K121724 for ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2, Substantially Equivalent on 2012-09-20. Applicant: Richard Wolf Medical Instruments Corp..

Clearance details

Applicant: Richard Wolf Medical Instruments Corp.
Product code: Code FCW
Advisory panel: Gastroenterology, Urology
Date received: 2012-06-12
Decision date: 2012-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FCW

product code FCW

Malfunction: 912
Other: 1
Total: 913

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.