21 CFR § 882.4600 Neurological Devices

§ 882.4600 Leukotome.

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

⚠ 2 pending changes to Part 882

(a) Identification. A leukotome is a device used to cut sections out of the brain.

(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 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001]

← § 882.4565 Field generator positioning device.§ 882.4650 Neurosurgical suture needle. →