Clearance Summary
Tristel OPH received FDA 510(k) clearance under submission number K242732, sponsored by Tristel Solutions , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2025-05-09.
- Submission: K242732
- Applicant / Sponsor: Tristel Solutions , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6886
- Decision date: 2025-05-09
Classification & Regulation
This clearance is catalogued under FDA product code QWS and 21 CFR 880.6886, within the General Hospital review panel as a Class II device.