K242732 is an FDA 510(k) clearance for the Tristel OPH. 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 , Ltd. (Cambridgeshire, GB). The FDA issued a Cleared decision on May 9, 2025, 241 days after receiving the submission on September 10, 2024.
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 | K242732 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2024 |
| Decision Date | May 09, 2025 |
| Days to Decision | 241 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| 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. |