STRYKER LED LIGHTSOURCE— 510(k) K082813

Substantially Equivalent

Stryker Corp.

FDA 510(k) clearance K082813 for STRYKER LED LIGHTSOURCE, Substantially Equivalent on 2008-12-19. Applicant: Stryker Corp..

Clearance details

Applicant: Stryker Corp.
Product code: Code FCW
Advisory panel: Gastroenterology, Urology
Date received: 2008-09-24
Decision date: 2008-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, 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.