Breast Implant Removal Device (BIRD)

Breast Implant Removal Device (BIRD) is an FDA 510(k)-cleared medical device (DEN220082) manufactured by Gaylord Solutions, LLC. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 19, 2023. Regulation: 8.