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.
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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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