WOODBINE/SOLOS, HIGH RESOLUTION 3-CHIP SURGICAL CAMERA

WOODBINE/SOLOS, HIGH RESOLUTION 3-CHIP SURGICAL CAMERA is an FDA 510(k)-cleared medical device (K953086) manufactured by Woodbine Optical Corp.. 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 September 21, 1995. Regulation: 8.