21 CFR § 876.4300 Gastroenterology-Urology Devices

§ 876.4300 Endoscopic electrosurgical unit and accessories.

Current through Sep 8, 2026 · Read all of Part 876

(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).

← § 876.4270 Colostomy rod.§ 876.4310 Endoscopic electrosurgical clip cutting system. →