SPY Laparoscope

SPY Laparoscope is an FDA 510(k)-cleared medical device (K252010) 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 July 23, 2025. Regulation: 8.