21 CFR 884.1700

§ 884.1700 Hysteroscopic insufflator.

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

Cite this

Citation: 21 CFR 884.1700, § 884.1700 Hysteroscopic insufflator, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90792
Permanent ID: ys:prov:90792@1
SHA-256: fdc41c830655ddf2b1118ee6574cc17df676e2632165d02fee0650918b85da07

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Full text

(a) Identification. A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope. (b) Classification. (1) Class II (performance standards). (2) Class I for tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation. The devices subject to this paragraph (b)(2) are 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.