QWS

Foam Or Gel Chemical Sterilant/High Level Disinfectant

Product code
QWS
Device name
Foam Or Gel Chemical Sterilant/High Level Disinfectant
Device class
Class 2
21 CFR
21 CFR 880.6886
Medical specialty
General Hospital
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
2 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-05-09.

NumberDecision dateApplicantDevice nameSummary
K2427322025-05-09Tristel Solutions , Ltd.Tristel OPHPDF

1 summaries are archived here for direct download.

Official FDA classification page: QWS
Classification and pathway per current FDA publications. Data from openFDA (CC0).