21 CFR 876.4300
§ 876.4300 Endoscopic electrosurgical unit and accessories.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 876.4300, § 876.4300 Endoscopic electrosurgical unit and accessories, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90298
- Permanent ID
ys:prov:90298@1- SHA-256
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.