DeviceClearance

VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 +2 more— 510(k) K242067

Substantially Equivalent

Olympus Corporations of the Americas

FDA 510(k) clearance K242067 for VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 +2 more, Substantially Equivalent on 2025-04-02. Applicant: Olympus Corporations of the Americas. Device class: 2.

Clearance details

Device name as filed
VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA
Applicant
Olympus Corporations of the Americas
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
Westborough, MA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code FET

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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.