Clearance Summary
Disposable Distal Attachment D-201 Series received FDA 510(k) clearance under submission number K250296, sponsored by Olympus Medical Systems Corp.. 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 2025-05-01.
- Submission: K250296
- Applicant / Sponsor: Olympus Medical Systems Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2025-05-01
Classification & Regulation
This clearance is catalogued under FDA product code FDS and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.