510(k) K242732
K242732 is an FDA 510(k) premarket notification submitted by Tristel Solutions , Ltd. for the device "Tristel OPH". The FDA issued a decision of Substantially Equivalent on May 9, 2025. 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
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 2025
- Date Received
- September 10, 2024
- Clearance Type
- Traditional
- 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.