21 C.F.R. § 884.1700 Hysteroscopic insufflator.
Title 21 - Food and Drugs
(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 12684–12720, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38808, July 25, 2001]
Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart B—Obstetrical and Gynecological Diagnostic Devices
§ 884.1700 Hysteroscopic insufflator.
