VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700) +2 more— 510(k) K251336
Substantially EquivalentOlympus Medical Systems Corp.
FDA 510(k) clearance K251336 for VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700) +2 more, Substantially Equivalent on 2025-11-12. Applicant: Olympus Medical Systems Corp.. Device class: 2.
Clearance details
- Device name as filed
- 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.
- Product code
- Code OWN
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hachioji-Shi, JP
Recent devices under product code OWN
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- K252341 — EVIS EXERA III BRONCHOVIDEOSCOPE (3 models)
- K251807 — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR
Adverse events under product code OWN
product code OWN- Malfunction
- 1,286
- Total
- 1,286
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.