L10 LED Light Source with AIM, L11 LED Light Source with AIM— 510(k) K191046

Substantially Equivalent

Stryker

FDA 510(k) clearance K191046 for L10 LED Light Source with AIM, L11 LED Light Source with AIM, Substantially Equivalent on 2019-05-10. Applicant: Stryker.

Clearance details

Applicant: Stryker
Product code: Code OWN
Advisory panel: Gastroenterology, Urology
Date received: 2019-04-19
Decision date: 2019-05-10
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OWN

product code OWN

Malfunction: 1,286
Total: 1,286

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.