882.4545 Shunt system implantation instrument.§ 882.4545 Shunt system implantation instrument.
(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.
(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.[44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000; 84 FR 71815, Dec. 30, 2019]