RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527

RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527 is an FDA 510(k)-cleared medical device (K010610) manufactured by Boston Scientific 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 March 26, 2001. Regulation: 8.