BrachyGel Vaginal Hydrogel Packing System

BrachyGel Vaginal Hydrogel Packing System is an FDA 510(k)-cleared medical device (DEN220052) manufactured by Brachyfoam, Inc. D/B/A Advaray. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 21, 2023. Regulation: 8.