TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5

TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5 is an FDA 510(k)-cleared medical device (K990475) manufactured by Kps & Assoc., Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 17, 1999. Regulation: 8.