e-CFR data is current as of February 23, 2021 |
Title 21 → Chapter I → Subchapter H → Part 882 → Subpart E → §882.4250 |
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart E—Neurological Surgical Devices
(a) Identification. A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site.
(b) Classification. Class II (performance standards).