DEN220041 is an FDA 510(k) submission for the Tristel Duo ULT. This device is classified as a Foam Or Gel Chemical Sterilant/high Level Disinfectant (Class II - Special Controls, product code QWS).
Submitted by Tristel Solutions Limited (Snailwell, GB). The FDA issued a Not Cleared (DENG) decision on June 2, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6886. 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) Number | DEN220041 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 29, 2022 |
| Decision Date | June 02, 2023 |
| Days to Decision | 338 days |
| Submission Type | Direct |
| Review Panel | General Hospital (HO) |
| Summary | - |
| Product Code | QWS - Foam Or Gel Chemical Sterilant/high Level Disinfectant |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6886 |
| 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. |