K251336
- 510(k) number
- K251336
- Device name
- VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)
- Applicant
- Olympus Medical Systems Corp. JP
- Product code
- OWN — Confocal Optical Imaging
- Decision date
- 2025-11-12
- Date received
- 2025-04-30
- 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: K251336.pdf
Official FDA record: K251336
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.