{"data":{"id":"us/21-cfr-882.4600","jurisdiction":"us","citation":"21 CFR 882.4600","heading":"Leukotome.","body":"(a) Identification. A leukotome is a device used to cut sections out of the brain.\n(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 882—NEUROLOGICAL DEVICES","Subpart E—Neurological Surgical Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"354509857c2c705acb97dbddf4dcf425373f06776ded68b5f437c9e81da6b9a2","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-882.4565","next":"us/21-cfr-882.4650"},"notice":"GroundRules: Original legal text. Not legal advice."}