K261260
- 510(k) number
- K261260
- Device name
- HD Camera Head OLYMPUS CH-S200-08-LB
- Applicant
- Olympus Medical Systems Corporation JP
- Product code
- FET — Endoscopic Video Imaging System/Component, Gastroent
- Decision date
- 2026-06-24
- Date received
- 2026-04-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K261260.pdf
Official FDA record: K261260
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.