QWS
- 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.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242732 | 2025-05-09 | Tristel Solutions , Ltd. | Tristel OPH |
Official FDA classification page: QWS
Classification and pathway per current FDA publications. Data from openFDA (CC0).