GM501 Wash with Phenol Red and Gentamicin

GM501 Wash with Phenol Red and Gentamicin is an FDA 510(k)-cleared medical device (K192503) manufactured by Hamilton Thorne Incorporated. 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 November 18, 2020. Regulation: 8.