Capenergy C Equipments RF C200 and C400 Drakarian
Summary
Capenergy Medical S.L. received 510(k) clearance for Capenergy C Equipments RF C200 and C400 Drakarian, a PBX device. Cleared on 2026-07-10.
Details
Source
510(k) Clearance
External ID
K253480
Action Date
2026-07-10
Status
Abbreviated
Category
device
Product Code
PBX
Product Description
Capenergy C Equipments RF C200 and C400 Drakarian. Product code: PBX.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 365 device clearances issued this month. Capenergy Medical S.L. has received 2 total clearances in our database.
Capenergy Medical S.L. has 2 FDA actions in our database, including 2 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 Capenergy Medical S.L. have FDA actions?
Capenergy Medical S.L. has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K253480" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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