Who is the manufacturer of DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL?

Deroyal Industries, Inc. filed the 510(k) submission for DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL (K961647).

What is the FDA product code for DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL?

510(k) clearance (submission type: Traditional).

What are the predicate devices for DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL?

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

Who can help prepare an FDA 510(k) submission like DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL

K961647 · Deroyal Industries, Inc. · GEI · Oct 8, 1996 · General, Plastic Surgery

Device Facts

Record ID	K961647
Device Name	DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL
Applicant	Deroyal Industries, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Oct 8, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

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.

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.

Indications for Use

Indicated for patients undergoing electrosurgical procedures requiring tissue removal or hemostasis via cutting or coagulation.

Regulatory Classification

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)

Related Devices

K982743 — DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBH · New Deantronics Taiwan , Ltd. · Sep 14, 1998
K190643 — Medline Electrocautery Pencil · Medline Industries, Inc. · May 6, 2019
K213786 — CiRX Single use electrosurgical pencil with non-coated and coated electrode · Ningbo Shun YE Medical Company, Ltd. · Jun 27, 2022
K231405 — Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode · Jiangsu Rong FU Kang Medical Instruments Co., Ltd. · Jan 18, 2024
K132199 — DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST · Deroyal Industries, Inc. · Oct 3, 2013

Submission Summary (Full Text)

{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. |