UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE

K970066 · Unimed Surgical Products, Inc. · GEI · Feb 18, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970066
• Device Name: UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE
• Applicant: Unimed Surgical Products, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Indications for Use

Indicated for cutting of soft tissue and coagulation during laparoscopic and arthroscopic surgical procedures.

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

• unimed Coated Electrode (K962935)
• unimed Laparoscopic Electrodes (K945030)
• unimed Suction-Irrigation Electrodes (K963338)

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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