21 CFR 878.1800 - Speculum and accessories.
(a)Identification. A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.
(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 § 878.9.