EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)

EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) is an FDA 510(k)-cleared medical device (K203450) manufactured by Capnostics, LLC. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 3, 2021. Regulation: 8.