21 CFR 882.4545 — Instrument, Shunt System Implantation

Neurology (NE) · Part 882 Subpart E—Neurological Surgical Devices · § 882.4545

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.

Classification Rationale

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
GYKInstrument, Shunt System Implantation113
PIYStainless Steel Instrument, Shunt System Implantation10
Innolitics

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