StacksVerified U.S. regulatory reference

21 CFR §882.4545

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (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.