PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical
Summary
Conmed Corporation received 510(k) clearance for PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter, a GEI device. Cleared on 2023-04-27.
Details
Source
510(k) Clearance
External ID
K230547
Action Date
2023-04-27
Status
Traditional
Category
device
Product Code
GEI
Product Description
PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter. Product code: GEI.
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 389 device clearances issued this month. Conmed Corporation has received 19 total clearances in our database.
Conmed Corporation has 31 FDA actions in our database, including 12 recalls and 19 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 31 FDA actions in our database, including 12 recalls and 19 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K230547" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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