21 C.F.R. § 888.4300

Depth gauge for clinical use.

Last amended: 2016Year: 2026Length: 80 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 888.4300 (2026)

(a) Identification. A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone. (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 § 888.9. [52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]
Cross-references to the CFR
888.9.
21 C.F.R. § 888.4300: Depth gauge for clinical use. | Justis AI