CoolSeal Trinity
Summary
Bolder Surgical, LLC received 510(k) clearance for CoolSeal Trinity, a GEI device. Cleared on 2023-11-15.
Details
Source
510(k) Clearance
External ID
K231012
Action Date
2023-11-15
Status
Traditional
Category
device
Product Code
GEI
Product Description
CoolSeal Trinity. 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 403 device clearances issued this month.
Bolder Surgical, LLC has 2 FDA actions in our database, including 1 recall and 1 clearance.
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 Bolder Surgical, LLC have FDA actions?
Bolder Surgical, LLC has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K231012" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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