UNIPOLAR OPTICAL BIOPSY FORCEPS

UNIPOLAR OPTICAL BIOPSY FORCEPS is an FDA 510(k)-cleared medical device (K983811) manufactured by Olympus Winter & Ibe GmbH. 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 December 23, 1998. Regulation: 8.