21 C.F.R. § 874.4800

Bone particle collector.

Last amended: 2016Year: 2026Length: 68 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 874.4800 (2026)

(a) Identification. A bone particle collector is a filtering device intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use. (b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9. [64 FR 10949, Mar. 8, 1999]
Cross-references to the CFR
874.9.
21 C.F.R. § 874.4800: Bone particle collector. | Justis AI