21 C.F.R. § 882.4525

Microsurgical instrument.

Last amended: 2016Year: 2026Length: 67 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 882.4525 (2026)

(a) Identification. A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures. (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]
Cross-references to the CFR
882.9.
21 C.F.R. § 882.4525: Microsurgical instrument. | Justis AI