← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K961087

# DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS (K961087)

_Debusk Knitting Mills, Div. Deroyal Industries · GEI · May 16, 1996 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K961087

## Device Facts

- **Applicant:** Debusk Knitting Mills, Div. Deroyal Industries
- **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md)
- **Decision Date:** May 16, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4400
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Indications for 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.

## 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

- ValleyLab
- Weck

## Submission Summary (Full Text)

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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  |

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K961087](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K961087)

**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).

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