← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K970066

# UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE (K970066)

_Unimed Surgical Products, Inc. · GEI · Feb 18, 1997 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K970066

## Device Facts

- **Applicant:** Unimed Surgical Products, Inc.
- **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md)
- **Decision Date:** Feb 18, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4400
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic

## Indications for Use

These electrosurgical devices are designed for cutting of soft tissue and coagulation.

## Device Story

Electrosurgical electrodes (laparoscopic, arthroscopy, suction-irrigation) coated with Emralon 333 or Teflon 420-104; dry lubricants reduce friction and eschar build-up; minimizes need for high power settings; reduces scraping requirements; improves OR efficiency; sterile, single-use; used by surgeons for tissue cutting and coagulation.

## Clinical Evidence

Bench testing only; no clinical data provided.

## Technological Characteristics

Electrosurgical electrodes; stainless steel base; coated with Emralon 333 or Teflon 420-104; available in various diameters, lengths, and tip configurations; sterile, single-use.

## 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

- unimed Coated Electrode ([K962935](/device/K962935.md))
- unimed Laparoscopic Electrodes ([K945030](/device/K945030.md))
- unimed Suction-Irrigation Electrodes ([K963338](/device/K963338.md))

## Submission Summary (Full Text)

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K 970066

# SAFETY AND EFFECTIVENESS SUMMARY

COMMON/USUAL NAME: Electrosurgical Electrodes  FEB 18 1997

PROPRIETARY NAME: *unimed* Coated Laparoscopic Electrode
*unimed* Coated Arthroscopy Electrode
*unimed* Coated Suction-Irrigation Electrode

CLASSIFICATION: CLASS II

MATERIALS: All materials used to manufacture the Coated Electrodes are non-toxic and have been used in other previously marketed devices.

DESCRIPTION: The *unimed* Coated Laparoscopic Electrode, *unimed* Coated Arthroscopy Electrode and the *unimed* Coated Suction-Irrigation Electrode are coated with Emralon 333 or Teflon 420-104. Both are dry lubricants which provide a low coefficient of friction and reduce eschar build-up during surgery and the need for higher power settings. Without eschar build-up that takes place with a standard stainless steel tip less scraping and inconvenience takes place resulting in greater OR efficiency.

Each coating is non-toxic, corrosion resistant, and therefore safe for the patient and the OR staff.

These electrosurgical devices are designed for cutting of soft tissue and coagulation. The electrodes are available in a variety of diameters, lengths and tip configurations.

The electrodes are available sterile, single use only.

SUBSTANTIAL EQUIVALENCE: This 510(k) notification represents the adding of a coating that is identical to the coatings on *unimed’s* Coated Electrode (K962935) to *unimed* Electrodes identified as *unimed* Laparoscopic Electrodes (K945030) and *unimed* Suction-Irrigation Electrodes (K963338).

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K970066](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K970066)

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