21 C.F.R. § 882.4560
Stereotaxic instrument.
Cite as 21 C.F.R. § 882.4560 (2026)
(a)
Identification.
A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.
(b)
Classification.
Class II (performance standards).