510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QWSClass II

Foam Or Gel Chemical Sterilant/High Level Disinfectant

21 CFR 880.6886 / General Hospital
FDA source (opens on fda.gov)

QWS is the FDA product code for Foam Or Gel Chemical Sterilant/High Level Disinfectant, a class II device type, regulated under 21 CFR 880.6886. FDA's definition for this code 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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QWS
Device name
Foam Or Gel Chemical Sterilant/High Level Disinfectant
FDA 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.
Regulation
21 CFR 880.6886
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QWS

By decision year
2 clearances under product code QWS with a decision year between 2023 and 2025, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QWS by decision year
YearClearances
20231
20251

Applicants with the most clearances

Product code QWS
Applicants holding the most 510(k) clearances under product code QWS
ApplicantClearances
Tristel Solutions, Ltd.2

Companies listing this code with FDA

Companies whose registered establishments list this code