Deroyal Electrosurgical Pencil, Rocker Style Without Holster, Deroyal Electrosurgical Pencil, Button Style Without Holst

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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

Trade Name

Electrosurgical Pencil EUDAMED

DeRoyal GUDID

Generic Name

Open-surgery electrosurgical electrode, monopolar, single-use

Model / Reference

88-000032

Primary DI / UDI-DI

00749756126403

Basic UDI-DI

B-00749756126403

510(k) Number

K132199 ↗

FDA Product Code

GEI

EMDN Code

K0299 Electrosurgery devices, single-use - other

GMDN Term

Open-surgery electrosurgical electrode, monopolar, single-use

Device Class

Class IIb EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 878.4400

EU market of registration

Netherlands

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

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See all devices from Deroyal Industries, Inc. →

• What types of surgical procedures is the Deroyal Electrosurgical Pencil designed for, and how does it differ from standard electrosurgical tools?

  The Deroyal Electrosurgical Pencil is designed for general and plastic surgery procedures, delivering high-frequency electrical current to remove tissue and control bleeding. Unlike standard tools, it offers two activation styles—rocker or button—without an integrated holster, providing flexibility in handling. Its PTFE-coated electrodes also reduce tissue adhesion, which can be particularly useful in delicate surgeries where minimizing trauma is important.

• Are the Deroyal Electrosurgical Pencils reusable, and if not, how are they packaged and stored?

  No, the Deroyal Electrosurgical Pencils are single-use devices. They are supplied in sterile units of 50 per case, ensuring each pencil is ready for immediate use without risk of cross-contamination. Storage should follow standard sterile supply protocols, keeping the sealed case in a clean, dry environment away from direct sunlight or extreme temperatures to maintain sterility and functionality.

• What cord lengths are available, and how does this affect drapeability during surgery?

  The Deroyal Electrosurgical Pencils come with either a 10-inch or 15-inch flexible cord, allowing surgeons to choose based on their preference for maneuverability and drapeability. The longer 15-inch cord provides greater reach and flexibility, reducing the need to reposition the generator or adjust the patient’s drape, while the shorter 10-inch option may be preferred in confined spaces or for precision control.

• Do these pencils require any special connectors, and are they compatible with most electrosurgical generators?

  Yes, the Deroyal Electrosurgical Pencils feature a three-prong plug, which is designed for compatibility with most standard electrosurgical generators. This universal connector ensures ease of use across different surgical setups, reducing the need for additional adapters or modifications. Always verify compatibility with your specific generator before use.

• Are there any material considerations for patients with latex allergies, and how is the sterility maintained?

  The Deroyal Electrosurgical Pencils are non-latex, making them suitable for patients with latex allergies. Sterility is maintained through individual packaging of single-use units, ensuring each pencil is sterile upon opening. The sealed case design prevents contamination before use, and the sterile field should be maintained during surgery as with any disposable medical device.