K-KATH URETHRAL CATHETER INTRODUCER

K-KATH URETHRAL CATHETER INTRODUCER is an FDA 510(k)-cleared medical device (K802878) manufactured by B&K Medical. 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 January 1, 1981. Regulation: 8.