
Coloplast A/S
Free shipping on orders over $99 · 30-day returns
CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH is an FDA 510(k)-cleared medical device (K854580) manufactured by Coloplast A/S. 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 12, 1985. Regulation: 8.