Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
Summary
C.R. Bard, Inc. received 510(k) clearance for Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories), a GEX device. Cleared on 2026-03-17.
Details
Source
510(k) Clearance
External ID
K252971
Action Date
2026-03-17
Status
Traditional
Category
device
Product Code
GEX
Product Description
Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories). Product code: GEX.
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. C.R. Bard, Inc. has received 14 total clearances in our database.
C.R. Bard, Inc. has 78 FDA actions in our database, including 64 recalls and 14 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 C.R. Bard, Inc. have FDA actions?
C.R. Bard, Inc. has 78 FDA actions in our database, including 64 recalls and 14 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K252971" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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