Tristel Duo ULT

DEN220041 is the FDA 510(k) clearance record for Tristel Duo ULT, a class II device, cleared for Tristel Solutions Limited on 2023-06-02 under FDA product code QWS (Foam Or Gel Chemical Sterilant/High Level Disinfectant). FDA's definition for product code QWS reads: "A foam or gel chemical sterilant/high level disinfectant is a germicide in the form of a foam or gel that is intended for use as the terminal step in high level disinfection of medical devices prior to patient use". FDA records list 2 510(k) clearances for Tristel Solutions Limited, from 2023-06-02 to 2025-05-09. As of 2026-09-10, FDA records show no recalls naming DEN220041.