CapsoCam Plus (SV-3) Capsule Endoscopy System

CapsoCam Plus (SV-3) Capsule Endoscopy System is an FDA 510(k)-cleared medical device (K242643) manufactured by CapsoVision, Inc.. 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 December 3, 2024. Regulation: 8.