StacksVerified U.S. regulatory reference

21 CFR §882.4250

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (b)Classification. Class II (performance standards).