(41 days)
These electrosurgical devices are designed for cutting of soft tissue and coagulation.
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.
This abstract document is a medical device summary for an electrosurgical electrode and does not contain information about acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic accuracy. The text describes the device, its materials, classification, and claims of substantial equivalence based on prior 510(k) notifications.
Therefore, I cannot provide the requested information.
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SAFETY AND EFFECTIVENESS SUMMARY
COMMON/USUAL NAME: Electrosurgical Electrodes
FEB 1 8 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 nontoxic 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).
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.