Malis Bipolar Electrosurgical System CMC-III

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

510(k) Number

K896541 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Valley Forge Bipolar Pen or Forceps

  Class II

  FDA 510(k) K910510 Active Cleared 22 Apr 1991

• Vally Forge Scientific Malis Bipolar Disposable Finger Operated Electrosurgical Instruments

  Class II

  FDA 510(k) K042604 Active Cleared 22 Oct 2004

• Bi-Tech I Bipolar Coagulator/Cutting System

  Class II

  FDA 510(k) K924188 Active Cleared 10 Dec 1992

• Valley Forge Scien-Tens Unit & Access. Lead Wire &

  Class II

  FDA 510(k) K853992 Active Cleared 21 Feb 1986

• Malis Surgical Loupes

  Class I

  FDA 510(k) K874845 Active Cleared 23 Dec 1987

• Malis 2000 Bipolar Electrosurgical System

  Class II

  FDA 510(k) K050364 Active Cleared 9 Mar 2005

See all devices from Valley Forge Scientific Corp. →

• What is the primary function of the Malis Bipolar Electrosurgical System CMC-III?

  This system is an electrosurgical unit engineered for bipolar cutting and coagulation. It uses microprocessor control to generate specific waveforms that deliver consistent power, which helps minimize tissue sticking and charring during surgical procedures.

• How does the system handle different tissue types?

  The device is capable of providing high energy output to cut through various tissue types, including dense fibrous layers. It achieves this by automatically adjusting to the specific power requirements of the tissue being treated.

• What is the regulatory status of this electrosurgical unit?

  The Malis Bipolar Electrosurgical System CMC-III has received FDA 510k clearance. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

• How is the device supplied to the user?

  The system is supplied as a generator unit designed to provide the necessary power and control for bipolar electrosurgical procedures.