(64 days)
The ENDOcare Electrosurgical Electrodes are designed for use in general surgery, urology, gynecology and orthopedics for cutting, coagulation, resection and vaporization of tissue including BPH (Benign Prostatic Hyperplasia), tumors, fibroids, cysts and obstructive tissue.
The ENDOcare Electrosurgical Electrodes are accessories that fit commercially available resectoscopes, cystoscopes, laproscopes and hysteroscopes, pencil grips and pistol grips. Each model has a different configuration which offers the surgeon a variety of tissue interaction tips depending on the specific surgical application.
This document does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert consensus, adjudication methods), or AI/algorithm performance. It primarily describes the device (ENDOcare Electrosurgical Electrodes), its biocompatibility, substantial equivalence to previously cleared devices, and sterilization methodology. There is no mention of a study to prove acceptance criteria are met, nor any quantitative performance metrics.
§ 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.