DeviceClearance

Product code QWS— General Hospital

Tristel Duo ULT

Classification name
Foam Or Gel Chemical Sterilant/High Level Disinfectant
Device class
Class 2
Regulation
21 CFR 880.6886
Advisory panel
General Hospital
Total cleared
2
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code QWS under 21 CFR 880.6886, via openFDA

Market context for product code QWS

FDA has cleared 2 devices under product code QWS between 2023 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QWS

Recent clearances under product code QWS

Data sourced from openFDA. This site is unofficial and independent of the FDA.