Secca Tubular Electrode Device, Model A4000

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

510(k) Number

K000170 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Conway Stuart Medical, Inc. →

• What is the Secca Tubular Electrode Device, Model A4000 used for?

  The Secca Tubular Electrode Device, Model A4000 is an electrosurgical instrument designed for tissue removal and hemostasis. It applies high-frequency electrical current to target tissue, enabling controlled excision and bleeding control during surgical procedures. Its tubular electrode design allows for precise application in specific anatomical regions, making it suitable for general and plastic surgery applications.

• Is the Secca Tubular Electrode Device, Model A4000 single-use or reusable?

  The Secca Tubular Electrode Device, Model A4000 is supplied as a reusable medical instrument. It is intended for use in sterile surgical environments, requiring proper cleaning, sterilization, and maintenance between procedures to ensure safety and functionality.

• What regulatory pathway was followed for the FDA clearance of this device?

  The Secca Tubular Electrode Device, Model A4000 received FDA clearance under the Special 510(k) Review pathway. It was classified under product code GEI (Electrosurgical Cutting and Coagulation Devices) and granted a decision of Substantially Equivalent by the FDA’s General and Plastic Surgery Advisory Committee.

• How should the Secca Tubular Electrode Device, Model A4000 be stored?

  Since this device is reusable, it must be stored in a clean, dry environment when not in use. Proper storage includes keeping it in its original packaging or a designated sterile storage area to prevent contamination. Follow manufacturer guidelines for maintenance and sterilization procedures to ensure longevity and safety.

• Are there any specific safety considerations for using this device in MRI environments?

  The provided regulatory data does not specify MRI safety information for the Secca Tubular Electrode Device, Model A4000. Clinicians should consult the manufacturer’s instructions for use and any additional safety guidelines before using this device in proximity to MRI equipment to avoid potential risks.