21 C.F.R. § 882.4250 Cryogenic surgical device.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart E—Neurological Surgical Devices
§ 882.4250 Cryogenic surgical device.

