QWS — Foam Or Gel Chemical Sterilant/High Level Disinfectant Class II

FDA Device Classification

Classification Details

Product Code
QWS
Device Class
Class II
Regulation Number
880.6886
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242732tristel solutionsTristel OPHMay 9, 2025
DEN220041tristel solutions limitedTristel Duo ULTJune 2, 2023