
Stryker
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1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM is an FDA 510(k)-cleared medical device (K182160) manufactured by Stryker. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 4, 2018. Regulation: 8.