OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE

OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE is an FDA 510(k)-cleared medical device (K970716) manufactured by Opticon Medical, Inc.. 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 May 15, 1997. Regulation: 8.