Clearance Summary
Epitomee received FDA 510(k) clearance under submission number K240544, sponsored by Epitomee Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2024-09-13.
- Submission: K240544
- Applicant / Sponsor: Epitomee Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5982
- Decision date: 2024-09-13
Classification & Regulation
This clearance is catalogued under FDA product code QFQ and 21 CFR 876.5982, within the Gastroenterology, Urology review panel as a Class II device.