QWS — Foam Or Gel Chemical Sterilant/High Level Disinfectant Class II
FDA product code QWS covers "Foam Or Gel Chemical Sterilant/High Level Disinfectant", a Class II medical device regulated under 21 CFR 880.6886. Submissions are reviewed by the General Hospital panel. At least 2 recent 510(k) clearances have been granted under this product code.
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.