{"data":{"id":"us/21-cfr-884.1730","jurisdiction":"us","citation":"21 CFR 884.1730","heading":"Laparoscopic insufflator.","body":"(a) Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.\n(b) Classification. (1) Class II (performance standards).\n(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). 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":"fe3812f3e18c37047ebea28e854ee114d192196bf339ff47d5b8cfa816e69eda","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-884.1720","next":"us/21-cfr-884.2050"},"notice":"GroundRules: Original legal text. Not legal advice."}