(274 days)
The gi 4000 Electrosurgical Generator is intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas in flexible endoscopic applications. The integrated lavage pump is intended to was tissue or mucosa within the gut when used in conjunction with washing catheters or bipolar endoscopic probes, endoscope water jet channels, or endoscope working channels. The Genii ArConnect™ Conducting Adapter is intended for use with the gi 4000 during argon assisted coagulation.
Not Found
This is an FDA clearance letter for a medical device (gi-4000 Electrosurgical Generator), not a study report. Therefore, it does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, or study methodologies. The document's purpose is to confirm that the FDA has reviewed the device and determined it is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
While the document references "Indications for Use," it does not provide data from studies to support these indications or detail how the device's performance meets specific acceptance criteria.
Therefore, I cannot provide the requested information from this document.
To answer your request, I would need a clinical study report or a technical performance report for the gi-4000 Electrosurgical Generator.
§ 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.