Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01

Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 is an FDA 510(k)-cleared medical device (K252874) manufactured by Serpex Medical, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 7, 2025. Regulation: 8.