4K Camera Head OLYMPUS CH-S700-08-LB— 510(k) K262079
Substantially EquivalentOlympus Medical Systems Corp.
FDA 510(k) clearance K262079 for 4K Camera Head OLYMPUS CH-S700-08-LB, Substantially Equivalent on 2026-09-10. Applicant: Olympus Medical Systems Corp.. Device class: 2.
Summary
The OLYMPUS CH-S700-08-LB is a 4K camera head, filed under FET, endoscopic video imaging systems and components. The code covers visualizing body cavities through an endoscope by projecting images to a monitor.
Class II, 21 CFR 876.1500, filed as a Traditional 510(k). The record lists Gastroenterology and Urology as the advisory panel and General and Plastic Surgery as the review panel.
Olympus Medical Systems filed from Tokyo, Japan. Review took 80 days (June 22 to September 10, 2026). The record doesn't say which Olympus video platform this camera head is built for.
Clearance details
- Applicant
- Olympus Medical Systems Corp.
- Product code
- Product code FET
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, JP
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Adverse events under product code FET
product code FET- Injury
- 313
- Malfunction
- 54,276
- Total
- 54,589
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.