Foam Or Gel Chemical Sterilant/High Level Disinfectant
The foam or gel chemical sterilant/high level disinfectant (product code QWS) is a Class 2 General Hospital device (regulation 880.6886) consisting of a germicide in foam or gel form intended for use as the terminal step in high level disinfection of medical devices prior to patient use. It requires 510(k) clearance. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QWS
- Device Class
- FDA class 2
- Regulation Number
- 880.6886
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.