Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices

Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices is an FDA 510(k)-cleared medical device (K201244) manufactured by Transmed7, 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 6, 2020. Regulation: 8.