{"data":{"id":"us/21-cfr-882.4545","jurisdiction":"us","citation":"21 CFR 882.4545","heading":"Shunt system implantation instrument.","body":"(a) Identification. A shunt system implantation instrument is an instrument used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt components under the skin.\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":"bf0023182170ec5ca47fc2e46a87671dcbed01911941bb39d602797152c4c634","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-882.4535","next":"us/21-cfr-882.4560"},"notice":"GroundRules: Original legal text. Not legal advice."}