ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is an FDA 510(k)-cleared medical device (K240664) manufactured by SurGenTec, LLC. 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 August 8, 2024. Regulation: 8.