QWS · Foam Or Gel Chemical Sterilant/High Level Disinfectant
General Hospital · 21 CFR 880.6886 · Class 2
Overview
| Product Code | QWS |
|---|---|
| Device Name | Foam Or Gel Chemical Sterilant/High Level Disinfectant |
| Regulation | 21 CFR 880.6886 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
Tristel Duo ULT is a high level disinfectant foam intended to disinfect cleaned, reusable, non-lumened ultrasound probes, including endocavity transvaginal and transrectal probes, and skin surface transducers that may contact non-intact skin. It generates chlorine dioxide foam from two precursor solutions (Base and Activator) dispensed via a pump mechanism. It is intended for use by qualified healthcare personnel at the point of care, requiring a 2-minute contact time at room temperature at or above the Minimum Recommended Concentration (MRC).
Classification Rationale
Class II (special controls). The device is a foam or gel chemical sterilant/high level disinfectant, regulated under 21 CFR 880.6886, which requires special controls in addition to general controls to provide reasonable assurance of safety and effectiveness.
Special Controls
In combination with the general controls of the FD&C Act, the foam or gel chemical sterilant/high level disinfectant is subject to the following special controls:
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242732 | Tristel OPH | Tristel Solutions , Ltd. | May 9, 2025 | SESE |
| DEN220041 | Tristel Duo ULT | Tristel Solutions Limited | Jun 2, 2023 | DENG |
Top Applicants
- Tristel Solutions , Ltd. — 1 clearance
- Tristel Solutions Limited — 1 clearance
