Disposable Hand-Switching ESU Pencil

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

510(k) Number

K925619 ↗

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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  FDA 510(k) K900767 Active Cleared 4 May 1990

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• Beamer One

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  FDA 510(k) K894663 Active Cleared 15 Sep 1989

See all devices from Beacon Laboratories, Inc. →

• What is the Disposable Hand-Switching ESU Pencil used for?

  This device is designed for electrosurgery procedures, enabling precise tissue dissection, coagulation, or cutting. The integrated hand-switch allows operators to control activation directly, reducing reliance on foot pedals while maintaining surgical precision. It connects to an electrosurgical unit (ESU) to deliver controlled electrical energy during procedures.

• Is the Beacon ESU Pencil single-use or reusable?

  The device is explicitly designed for single-use only and is not intended for reuse or reprocessing. Its disposable construction ensures no cross-contamination between patients, adhering to sterile surgical protocols. Always follow manufacturer guidelines to maintain sterility and compliance.

• How is the Disposable Hand-Switching ESU Pencil supplied, and what sterility guarantees are included?

  The device is supplied as a sterile, single-use unit in its packaging. Sterility is maintained through the manufacturer’s validated processes, ensuring it is ready for immediate surgical use without additional sterilization. Always inspect packaging for integrity before use to confirm sterility.

• Does this device require foot pedals, or can it be operated by hand?

  Unlike traditional ESU systems, this pencil features a built-in hand-switch, allowing operators to activate the device directly with their hand. This eliminates the need for separate foot pedals, improving ergonomics and workflow efficiency during procedures.

• What storage instructions should be followed to preserve sterility?

  Store the device in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposure to moisture or contaminants, as this could compromise sterility. Follow the manufacturer’s specific storage guidelines provided in the packaging instructions.