K250949
- 510(k) number
- K250949
- Device name
- Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)
- Applicant
- Olympus Medical Systems Corporation JP
- Product code
- ODC — Endoscope Channel Accessory
- Decision date
- 2025-07-16
- Date received
- 2025-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K250949.pdf
Official FDA record: K250949
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.