{"data":{"id":"us/21-cfr-884.1700","jurisdiction":"us","citation":"21 CFR 884.1700","heading":"Hysteroscopic insufflator.","body":"(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.\n(b) Classification. (1) Class II (performance standards).\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES","Subpart B—Obstetrical and Gynecological Diagnostic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"ee1743a07c65e316381499cebfb9d8bba49759456c2cdef8dc936e083563137d","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-884.1690","next":"us/21-cfr-884.1710"},"notice":"GroundRules: Original legal text. Not legal advice."}