1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality

1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality is an FDA 510(k)-cleared medical device (K260185) manufactured by Stryker Endoscopy. 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 February 17, 2026. Regulation: 8.