K251997
- 510(k) number
- K251997
- Device name
- Single-Use Biopsy Valve (MAJ-1555)
- Applicant
- Olympus Medical Systems Corporation JP
- Product code
- OCX — Endoscopic Irrigation/Suction System
- Decision date
- 2025-09-25
- Date received
- 2025-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K251997.pdf
Official FDA record: K251997
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.