(86 days)
Electro-Lube is a single patient use device that is intended to be used on electrodes to reduce sticking.
Electro-Lube is a single patient use device that is intended to be used on electrodes to reduce sticking.
This document is a 510(k) premarket notification decision letter from the FDA for the "Electro-Lube" device. It does not contain any information about acceptance criteria, device performance, or any studies conducted on the device.
The letter is a regulatory compliance document, stating that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed. It lists the device's indications for use and general regulatory requirements.
Therefore, I cannot provide the requested information based on the given input, as it is not present in the document.
§ 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.