NMI · Laparoscopic Insufflator And Accessories, Reprocessed
Obstetrics/Gynecology · 21 CFR 884.1730 · Class 1
Overview
| Product Code | NMI |
|---|---|
| Device Name | Laparoscopic Insufflator And Accessories, Reprocessed |
| Regulation | 21 CFR 884.1730 |
| Device Class | Class 1 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
(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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
