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Current as of January 02, 2025 | Updated by Findlaw Staff
(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.
(b) Classification.
(1) Class II (performance standards).
(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.
Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.884.1730 Laparoscopic insufflator - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-884-1730/
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