510(k) DEN220041
DEN220041 is an FDA 510(k) premarket notification submitted by Tristel Solutions Limited for the device "Tristel Duo ULT". The FDA issued a decision of De Novo Granted on June 2, 2023. The device falls under product code QWS (Foam Or Gel Chemical Sterilant/High Level Disinfectant), a Class II device regulated under 21 CFR 880.6886.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- June 2, 2023
- Date Received
- June 29, 2022
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Foam Or Gel Chemical Sterilant/High Level Disinfectant
- Device Class
- Class II
- Regulation Number
- 880.6886
- Review Panel
- HO
- Submission Type
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.