K253646
- 510(k) number
- K253646
- Device name
- Single Use Distal Cover MAJ-2315 (MAJ-2315)
- Applicant
- Olympus Medical Systems Corp. JP
- Product code
- FDT — Duodenoscope And Accessories, Flexible/Rigid
- Decision date
- 2026-02-22
- Date received
- 2025-11-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253646.pdf
Official FDA record: K253646
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.