21 CFR § 882.4560 Neurological Devices

§ 882.4560 Stereotaxic instrument.

Current through Sep 8, 2026 · Read all of Part 882

⚠ 2 pending changes to Part 882

(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).

← § 882.4545 Shunt system implantation instrument.§ 882.4565 Field generator positioning device. →