VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEA
Summary
Olympus Corporations of the Americas received 510(k) clearance for 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, a FET device. Cleared on 2025-04-02.
Details
Source
510(k) Clearance
External ID
K242067
Action Date
2025-04-02
Status
Traditional
Category
device
Product Code
FET
Product Description
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. Product code: FET.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Olympus Corporations of the Americas have FDA actions?
This is the only FDA action we have on record for Olympus Corporations of the Americas in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K242067" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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