← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K961647

# DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL (K961647)

_Deroyal Industries, Inc. · GEI · Oct 8, 1996 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K961647

## Device Facts

- **Applicant:** Deroyal Industries, Inc.
- **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md)
- **Decision Date:** Oct 8, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4400
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic

## Indications for Use

The DeRoyal Cautery Pencil is indicated for use whenever an electrosurgical procedure requires the removal of tissue or the control of bleeding by either cutting or coagulation.

## Device Story

Electrosurgical cautery pencil; used in surgical procedures for tissue removal and hemostasis. Device delivers high-frequency electrical current to surgical site. Operated by surgeons/clinicians in clinical settings. Tip design facilitates cutting and coagulation. Titanium Nitride coating provides anti-stick properties. Device connects to standard electrosurgical generators.

## Clinical Evidence

Bench testing only; no clinical data provided.

## Technological Characteristics

Materials: Stainless steel tip, PVC cable insulation. Coating: Titanium Nitride (anti-stick). Dimensions: 6.0" pencil body, 10' cable. Energy source: High-frequency electrical current from external electrosurgical generator. Principle: Electrosurgical cutting and coagulation.

## Regulatory Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

## Predicate Devices

- DeBusk Technology Corporation (no 510(k) number provided)

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

DEROYAL INDUSTRIES, INC.
ELECTROSURGICAL CAUTERY PENCIL
K 961647
510(k) Summary
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED
OCT - 8 1996

## SUBMITTER INFORMATION

NAME: DeRoyal Industries, Inc.
ADDRESS: 200 DeBusk Lane
Powell, TN 37849
TELEPHONE: (423) 938-7828
CONTACT: Debra F. Manning
DATE OF PREPARATION: April 22, 1996

## DEVICE NAMES

NAME: DeRoyal Industries, Inc. Electrosurgical Cautery Pencil
COMMON/USUAL NAME: Cautery Pencil
CLASSIFICATION NAME (if known): Electrosurgical Cutting & Coagulation Device and Accessories (79 GEI)

## PREDICATE OR LEGALLY MARKETED DEVICES

DeBusk Technology Corporation

## DEVICE DESCRIPTION

The DeRoyal Industries, Inc. Electrosurgical Cautery Pencil functions in the same manner as predicate devices in that it is intended to be used in electrosurgical procedures to remove tissue and control bleeding. The device can be used for both cutting and coagulating. Device Design/Materials Used/Physical Properties: The DeRoyal Industries, Inc. Electrosurgical Cautery Pencil is made of materials commonly used for their purpose. The concept of use is that the device is intended to remove tissue and control bleeding by use of high frequency electrical current.

## DEVICE INTENDED USE

The DeRoyal Cautery Pencil is indicated for use whenever an electrosurgical procedure requires the removal of tissue or the control of bleeding by either cutting or coagulation.

## TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)

|  Characteristic | DeRoyal Device | DeBusk Technology Device | Rationale  |
| --- | --- | --- | --- |
|  Length of Pencil Body | 6.0" | 6.0" |   |
|  Length of Cable | 10'0" | 10'0" |   |
|  Material of Outer Cable Insulation | PVC | PVC |   |
|  Method of Manufacturing of Tip | Stamped and formed from sheet of stainless steel | Stamped and formed from sheet of stainless steel |   |
|  Tip Coating | Titanium Nitride | None | Provides a non-toxic, anti-stick, lubricated surface.  |

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K961647](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K961647)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com