Tristel OPH
FDA 510(k) clearance K242732 · decided 2025-05-09
Clearance details
- K-number
- K242732
- Device name
- Tristel OPH
- Applicant
- Tristel Solutions , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-09-10
- Decision date
- 2025-05-09
- Days to decision
- 241 days
- Clearance type
- Traditional
- Product code
- QWS
- Device class
- 2
- Regulation number
- 880.6886
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Cambridgeshire, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Tristel Duo ULT (DEN220041) | Tristel Solutions Limited | 2023-06-02 |
Recalls involving this device
No recalls on record reference this clearance.