21 CFR 884.5920

§ 884.5920 Vaginal insufflator.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 884.5920, § 884.5920 Vaginal insufflator, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90865
Permanent ID: ys:prov:90865@1
SHA-256: 0e1ccb396f1e3a9f38636650b61b1ba17fe40be7d1999a6f23f68c54b5578ec3

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Full text

(a) Identification. A vaginal insufflator is a device used to treat vaginitis by introducing medicated powder from a hand-held bulb into the vagina through an open speculum. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.