Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6886](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6886) → QWS — Foam Or Gel Chemical Sterilant/High Level Disinfectant

# QWS · Foam Or Gel Chemical Sterilant/High Level Disinfectant

_General Hospital · 21 CFR 880.6886 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/QWS

## Overview

- **Product Code:** QWS
- **Device Name:** Foam Or Gel Chemical Sterilant/High Level Disinfectant
- **Regulation:** [21 CFR 880.6886](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6886)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## 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](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/QWS/K242732.md) | Tristel OPH | Tristel Solutions , Ltd. | May 9, 2025 | SESE |
| [DEN220041](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/QWS/DEN220041.md) | Tristel Duo ULT | Tristel Solutions Limited | Jun 2, 2023 | DENG |

## Top Applicants

- Tristel Solutions , Ltd. — 1 clearance
- Tristel Solutions Limited — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/QWS](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/QWS)

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