K260856
- 510(k) number
- K260856
- Device name
- Disposable Distal Attachment D-201-13404
- Applicant
- Olympus Medical Systems Corporation JP
- Product code
- FDS — Gastroscope And Accessories, Flexible/Rigid
- Decision date
- 2026-08-27
- Date received
- 2026-03-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K260856.pdf
Official FDA record: K260856
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.