PlumeSafe X5 Smoke Management System
Summary
Conmed Corporation received 510(k) clearance for PlumeSafe X5 Smoke Management System, a FYD device. Cleared on 2024-08-05.
Details
Source
510(k) Clearance
External ID
K240127
Action Date
2024-08-05
Status
Traditional
Category
device
Product Code
FYD
Product Description
PlumeSafe X5 Smoke Management System. Product code: FYD.
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 413 device clearances issued this month. Conmed Corporation has received 17 total clearances in our database.
Conmed Corporation has 29 FDA actions in our database, including 12 recalls and 17 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 Conmed Corporation have FDA actions?
Conmed Corporation has 29 FDA actions in our database, including 12 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K240127" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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