Hand Controlled Electrosurgical Pencils

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

510(k) Number

K896626 ↗

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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• Thermogard & Thermogard Plus Abc

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• Conmed Universal Plus

  Class II

  FDA 510(k) K934828 Active Cleared 7 Mar 1994

• Electrosurgical Dispersive Electrode

  Class II

  FDA 510(k) K983782 Active Cleared 25 Jan 1999

• Bend-A-Beam Hand Control Malleable ABC Handpiece

  Class II

  FDA 510(k) K961505 Active Cleared 18 Jul 1996

• Exactrace Adult Foam Monitoring ECG Electrode Conmed Model 1510 and Instatrace Adult Diaphoretic Foam ECG Electrode Conm

  Class II

  FDA 510(k) K963787 Active Cleared 11 Mar 1997

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• Are these electrosurgical pencils designed for single-use or can they be reused in the operating room?

  These hand-controlled electrosurgical pencils are reusable and built for repeated use in surgical settings. They are autoclavable, meaning they can be sterilized via steam autoclave for reuse, which is standard for reusable electrosurgical tools in the OR.

• What types of hand controls do these pencils come with, and how do they integrate with foot pedals?

  The pencils are supplied with either push-button or rocker switch hand controls, allowing surgeons to activate the electrosurgical current manually. They are also compatible with foot pedals, enabling hands-free operation for added precision during procedures.

• What cable lengths are available for these electrosurgical pencils, and how might that affect their use?

  These pencils come with standard cable lengths of either 10 feet or 15 feet, which provide flexibility depending on the surgical setup. Longer cables (15ft) may offer more mobility for the surgeon, while shorter cables (10ft) could reduce clutter in tight OR spaces.

• How are these devices regulated, and what does the FDA’s classification under General and Plastic Surgery mean for their use?

  These pencils are classified under the FDA’s General and Plastic Surgery advisory committee and fall under the Product Code GEI (Electrosurgical Cutting and Coagulation Devices). They were granted 510(k) clearance (K896626) via a Traditional Review pathway, meaning they were deemed substantially equivalent to a legally marketed predicate device. This classification ensures they meet FDA safety and performance standards for surgical electrosurgical tools.