(79 days)
The ArthroCare Bipolar Loop Electrosurgery System is a bipolar electrosurgical device intended for use in patients requiring endoscopic surgery for general urological procedures. Urological tissue can be resected using this System, such as the prostate, in procedures including transurethral prostatectomy (TURP) and transurethral incisions in the prostate (TUIP), as well as tumors of the bladder wall. The System has been shown to be effective in tissue resection, ablation, and excision, as well as in hemostasis of blood vessels. It is intended for endoscopic procedures using saline solution, Ringer's lactate, or other conductive solutions as irrigants, under direct or video-assisted fiberoptic visualization.
The ArthroCare Bipolar Loop Electrosurgery System is a bipolar, high frequency electrosurgical system consisting of three components: an electrosurgical generator called the Controller; a disposable, bipolar, single use Loop Electrode; and a reusable Patient Cable.
PMA/510(k) summary does not contain the performance data. No acceptance criteria mentioned.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).