Instrument Exit Point on Touch Surgery™ Aide

Instrument Exit Point on Touch Surgery™ Aide is an FDA 510(k)-cleared medical device (K253984) manufactured by Covidien, 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 June 3, 2026. Regulation: 8.