Optical Fiber for ENT Applications

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K944151 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Cardiogenes →

• What is the Optical Fiber for ENT Applications used for?

  The Optical Fiber for ENT Applications is a medical device designed specifically for use in ear, nose, and throat procedures. It functions as an optical fiber component for various medical applications within the ENT field.

• Is this device single-use or reusable?

  The available data does not specify whether the Optical Fiber for ENT Applications is designed for single-use or reusable purposes. Additional information regarding sterility and usage status would need to be obtained from the manufacturer.

• What regulatory approvals does this device have?

  The Optical Fiber for ENT Applications has received FDA 510(k) clearance with product code GEX. It was determined to be substantially equivalent to other devices in this category through the traditional clearance process.

• What are the storage requirements for this device?

  Specific storage requirements for the Optical Fiber for ENT Applications are not provided in the available data. For proper storage instructions, it would be necessary to consult the manufacturer's documentation or contact Cardiogenes directly.