← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K961097

# ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES (K961097)

_Debusk Knitting Mills, Div. Deroyal Industries · GEI · Jun 3, 1996 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K961097

## Device Facts

- **Applicant:** Debusk Knitting Mills, Div. Deroyal Industries
- **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md)
- **Decision Date:** Jun 3, 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 Grounding Pad Adapter is indicated for use whenever the ESU machine requires a grounding pad of the type provided by SurgiMate, or the connector on the SurgiMate pad does not match the intended jack of the ESU machine but its use would make the electrical connection compatible.

## Device Story

Device acts as passive electrical interface adapter; connects electrosurgical grounding pad to electrosurgical unit (ESU) jack. Input: proprietary grounding pad connector; Output: target machine connector. Operation: direct wiring conversion; no circuit alteration; no performance impact on original circuit. Used in clinical settings (OR/procedure rooms) by surgical staff. Facilitates electrical compatibility between mismatched hardware components; ensures grounding circuit continuity for patient safety during electrosurgery.

## Clinical Evidence

Bench testing only; no clinical data provided. Equivalence established through design comparison and functional similarity to legally marketed devices.

## Technological Characteristics

Passive electrical adapter; direct wiring configuration; non-sterile; proprietary input connector; target machine output connector. No active components or software.

## 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

- 3M (not specified)
- Birtcher (not specified)
- ValleyLab (not specified)

## 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}

K 961097

JUN - 3 1996

DeRoyal Industries, Inc. Electrosurgical Grounding Pad Adapters

510(k) Summary

## SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED

## 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 Grounding Pad Adapters
COMMON/USUAL NAME: Electrosurgical Grounding Pad Adapters
CLASSIFICATION NAME (if known): Electrosurgical Cutting & Coagulation Device & Accessories

## PREDICATE OR LEGALLY MARKETED DEVICES

3M
Birtcher
ValleyLab

## DEVICE DESCRIPTION

The DeRoyal Surgical Electrosurgical Grounding Pad Adapter functions in the same manner as predicate devices in that it is used to connect one type of electrosurgical grounding pad to a particular type of jack on the electrosurgical cautery machine being used.

Device Design/Materials Used/Physical Properties: The DeRoyal Grounding Pad Adapter is made of materials commonly used for their 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 Grounding Pad Adapter is indicated for use whenever the ESU machine requires a grounding pad of the type provided by SurgiMate, or the connector on the SurgiMate pad 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 grounding pad connector | Same  |
|  Output Connector | Target machine connector | Same  |
|  Sterility | Non-sterile | Same  |
|  Circuit | Direct wiring from input connector to output connector | Same  |

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K961097](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K961097)

**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