(17 days)
This instrument has been designed for general and endoscopic electrosurgery including polypectomy, TUR, and laparoscopy (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light source, and ancillary equipment.
This instrument has been designed for general and endoscopic electrosurgery including polypectomy, TUR, and laparoscopy (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light source, and ancillary equipment.
This document describes the UES-30 Electrosurgical Unit, a Class II medical device, for which a 510(k) premarket notification was submitted. The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory submission for premarket clearance and focuses on substantial equivalence to a predicate device.
Therefore, the requested information (points 1-9) cannot be extracted from the provided text as it is not present.
§ 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.