Who is the manufacturer of DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS?

Debusk Knitting Mills, Div. Deroyal Industries filed the 510(k) submission for DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS (K961087).

What is the FDA product code for DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS?

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 SURGICAL (SURGIMATE) PENCIL ADAPTERS?

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

Who can help prepare an FDA 510(k) submission like DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS?

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 SURGICAL (SURGIMATE) PENCIL ADAPTERS

K961087 · Debusk Knitting Mills, Div. Deroyal Industries · GEI · May 16, 1996 · General, Plastic Surgery

Device Facts

Record ID	K961087
Device Name	DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS
Applicant	Debusk Knitting Mills, Div. Deroyal Industries
Product Code	GEI · General, Plastic Surgery
Decision Date	May 16, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2

Intended Use

The DeRoyal Cautery Pencil Adapter is indicated for use whenever the ESU machine requires a Cautery Pencil of the type provided by SurgiMate, or the connector on the SurgiMate Pencil does not match the intended jack of the ESU machine but its use would make the electrical connection compatible.

Device Story

Device functions as electrical connector adapter; bridges proprietary cautery pencil connectors to specific electrosurgical unit (ESU) machine jacks. Operates via direct wiring; no circuit alteration; no performance impact on original ESU circuit. Used in clinical settings by surgical staff. Enables compatibility between mismatched surgical equipment; ensures electrical continuity for electrosurgical cutting and coagulation procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Passive electrical adapter; direct wiring from input connector to output connector. Materials are standard for electrosurgical accessories. Non-sterile. No active components, software, or energy source.

Indications for Use

Indicated for use in clinical settings where an electrosurgical unit (ESU) requires a specific cautery pencil connector type that does not match the available ESU machine jack, facilitating electrical compatibility between the pencil and the machine.

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

ValleyLab
Weck

Related Devices

K961097 — ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES · Debusk Knitting Mills, Div. Deroyal Industries · Jun 3, 1996
K971540 — AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR CABLE/CORD · American Biosurgical, Inc. · Aug 14, 1997
K111262 — ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP · Olsen Medical · May 23, 2012
K241621 — Da Vinci Monopolar and Bipolar Adapters (378896) · Intuitive Surgical · Aug 2, 2024
K133167 — MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORD · Intuitive Surgical, Inc. · Jan 7, 2014

Submission Summary (Full Text)

{0} DeRoyal Industries, Inc. Electrosurgical Cautery Pencil Adapters 510(k) Summary K961087 # SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED MAY 16 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: March 18, 1996 ## DEVICE NAMES NAME: DeRoyal Surgical (SurgiMate) Electrosurgical Cautery Pencil Adapters COMMON/USUAL NAME: Electrosurgical Cautery Pencil Adapters CLASSIFICATION NAME (if known): Electrosurgical Cutting & Coagulation Device & Accessories ## PREDICATE OR LEGALLY MARKETED DEVICES ValleyLab Weck ## DEVICE DESCRIPTION The DeRoyal Surgical Electrosurgical Cautery Pencil Adapter functions in the same manner as predicate devices in that it is used to connect one type of electrosurgical Cautery Pencil to a particular type of jack on the electrosurgical cautery machine being used. Device Design/Materials Used/Physical Properties: The DeRoyal Cautery Pencil Adapter is made of materials commonly used for its purpose. The concept of use is that the adapter converts one type of connection to another type of connection without any alteration of the circuit or any impact on the performance of the original circuit. ## DEVICE INTENDED USE The DeRoyal Cautery Pencil Adapter is indicated for use whenever the ESU machine requires a Cautery Pencil of the type provided by SurgiMate, or the connector on the SurgiMate Pencil does not match the intended jack of the ESU machine but its use would make the electrical connection compatible. ## TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S) | Characteristic | DeRoyal Device | Other Devices | | --- | --- | --- | | Input Connector | Proprietary cautery pencil connector | Same | | Output Connector | Target machine connector | Same | | Sterility | Non-sterile | Same | | Circuit | Direct wiring from input connector to output connector | Same |