Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)
Summary
Applied Medical Resources Corporation received 510(k) clearance for Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator), a GEI device. Cleared on 2025-10-31.
Details
Source
510(k) Clearance
External ID
K252412
Action Date
2025-10-31
Status
Traditional
Category
device
Product Code
GEI
Product Description
Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator). Product code: GEI.
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. Applied Medical Resources Corporation has received 8 total clearances in our database.
Applied Medical Resources Corporation has 8 FDA actions in our database, including 8 clearances.
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 Applied Medical Resources Corporation have FDA actions?
Applied Medical Resources Corporation has 8 FDA actions in our database, including 0 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K252412" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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