SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)

SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC) is an FDA 510(k)-cleared medical device (K974730) manufactured by Graphic Controls Corp.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 13, 1998. Regulation: 8.