MF 360B Electrosurgical Unit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K823923 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Fiber Optic Adapter #60-0892

  Class I

  FDA 510(k) K802774 Active Cleared 16 Dec 1980

• Fiber Optic Light Guide CAT#60-0768

  Class I

  FDA 510(k) K802767 Active Cleared 16 Dec 1980

• Fiber Optic Headlight #60-0766766

  Class II

  FDA 510(k) K802770 Active Cleared 11 Dec 1980

• Fiber Optic ADAPTERS#60-0893

  Class II

  FDA 510(k) K810300 Active Cleared 27 Feb 1981

• A.T.S. 1500 Tourniquet

  Class I

  FDA 510(k) K870784 Active Cleared 18 Mar 1987

• Single Use Ball Electrode

  Class II

  FDA 510(k) K780976 Active Cleared 22 Jun 1978

See all devices from Aspen Laboratories, Inc. →

• What is the MF 360B Electrosurgical Unit used for?

  The MF 360B Electrosurgical Unit is designed to provide controlled electrical energy for surgical procedures. It facilitates precise tissue dissection, coagulation, and haemostasis, making it suitable for general and plastic surgery environments where accurate cutting and sealing of tissues are required.

• Is the MF 360B Electrosurgical Unit reusable or single-use?

  The MF 360B Electrosurgical Unit is a reusable medical device. To maintain its safety and functionality, it must undergo proper maintenance and sterilisation protocols between uses, as outlined by the manufacturer’s guidelines.

• What regulatory clearance does the MF 360B Electrosurgical Unit hold?

  The MF 360B Electrosurgical Unit holds FDA 510(k) clearance under product code GEI, with a decision date of February 15, 1983. This clearance indicates that the device is considered substantially equivalent to a legally marketed predicate device and is regulated under classification 878.4400.

• Does the MF 360B Electrosurgical Unit come with specific sterility or MRI safety information?

  The available data for the MF 360B Electrosurgical Unit does not provide explicit details regarding sterility or MRI safety. Users should consult the manufacturer’s instructions for proper handling, maintenance, and any additional safety considerations.

• What advisory committee reviewed the MF 360B Electrosurgical Unit?

  The MF 360B Electrosurgical Unit was reviewed by the Surgical Devices Panel (SU) of the FDA’s advisory committee. This panel evaluates devices intended for general and plastic surgery applications, ensuring their safety and effectiveness for clinical use.