Model 5001 Micromanipulator for Use W/Tf-25 CO2

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K873246 ↗

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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• What is the Model 5001 Micromanipulator used for?

  The Model 5001 Micromanipulator is a precision instrument designed for fine manipulation during medical procedures, specifically intended for use in general and plastic surgery settings when paired with the TF-25 CO2 system.

• How is the Model 5001 Micromanipulator supplied?

  The device is supplied by Coherent Medical Group with specific model numbers and configurations as specified by the manufacturer to ensure compatibility with the TF-25 CO2 system.

• What is the regulatory status of the Model 5001 Micromanipulator?

  The Model 5001 Micromanipulator is authorized under FDA 510K clearance with K-number K873246, classified as substantially equivalent for use in general and plastic surgery procedures.

• Is the Model 5001 Micromanipulator reusable or single-use?

  The device data does not specify whether the Model 5001 Micromanipulator is designed for single-use or multiple uses, as this information is not provided in the regulatory documentation.