Malis Bipolar Pen

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

510(k) Number

K853168 ↗

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 types of surgical procedures is the Malis Bipolar Pen intended to assist with, and why is its bipolar design considered an advantage?

  The Malis Bipolar Pen is designed for cutting and coagulation of tissue using high-frequency radiofrequency (RF) current, making it suitable for controlled surgical procedures in general and plastic surgery. Its bipolar design delivers current directly between two electrodes, reducing the risk of unintended current dispersion to surrounding tissues. This precision minimizes collateral damage and improves safety during delicate operations.

• Is the Malis Bipolar Pen reusable, or is it meant for single-use? How should it be prepared before use?

  The Malis Bipolar Pen is supplied as a single-use accessory and is not intended for reuse. Since it is not sterile at shipment, it must be sterilized prior to use following standard medical device sterilization protocols to ensure safety and efficacy in the operating room.

• What system is required for the Malis Bipolar Pen to function, and how is it classified under regulatory standards?

  The Malis Bipolar Pen is designed exclusively for use with the Valley Forge Scientific 300 Bipolar System. It is classified as a Class II device under the FDA’s Special Controls for electrosurgical accessories, with clearance (K853168) granted through the Traditional 510(k) review pathway, ensuring compliance with U.S. regulatory requirements for electrosurgical tools.

• What product code and advisory committee category does the Malis Bipolar Pen fall under in regulatory filings?

  The Malis Bipolar Pen is categorized under the product code GEI (Electrosurgical, Cutting & Coagulation & Accessories) and was reviewed by the SU (Surgical) advisory committee during its FDA 510(k) submission process. These classifications reflect its intended use as a hand-held electrosurgical accessory for controlled tissue manipulation.