1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes— 510(k) K211202

Substantially Equivalent

Stryker

FDA 510(k) clearance K211202 for 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes, Substantially Equivalent on 2021-08-06. Applicant: Stryker.

Clearance details

Applicant: Stryker
Product code: Code GWG
Advisory panel: Neurology
Date received: 2021-04-22
Decision date: 2021-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

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.