(203 days)
Pneumoperitoneum Insufflation Needle is intended for use during Endoscopic procedures, to establish a pneumoperitoneum prior to abdominal endoscopy.
Not Found
This document (a 510(k) clearance letter) does not contain information on acceptance criteria or a study proving that the device meets acceptance criteria. It only indicates that the device (Pneumoperitoneum Insufflation Needle) is substantially equivalent to legally marketed predicate devices and is cleared for marketing.
Therefore, I cannot provide the requested information.
§ 884.1730 Laparoscopic insufflator.
(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.