K250296
- 510(k) number
- K250296
- Device name
- Disposable Distal Attachment D-201 Series
- Applicant
- Olympus Medical Systems Corp. JP
- Product code
- FDS — Gastroscope And Accessories, Flexible/Rigid
- Decision date
- 2025-05-01
- Date received
- 2025-01-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250296.pdf
Official FDA record: K250296
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.