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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 884 - Obstetrical and Gynecological Devices |
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Subpart B - Obstetrical and Gynecological Diagnostic Devices |
§ 884.1700 - Hysteroscopic insufflator.
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§ 884.1700 Hysteroscopic insufflator.
(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.
[45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38808, July 25, 2001]