Koala Intrauterine Pressure Catheter (IPC-5000E)

Koala Intrauterine Pressure Catheter (IPC-5000E) is an FDA 510(k)-cleared medical device (K250897) manufactured by Clinical Innovations, LLC. 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 May 21, 2025. Regulation: 8.