21 CFR 884.1730 — Insufflator, Laparoscopic
Obstetrics/Gynecology (OB) · Part 884 Subpart B—Obstetrical and Gynecological Diagnostic Devices · § 884.1730
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HIF | Insufflator, Laparoscopic | 2 | 177 | |
| NKC | Tubing/Tubing With Filter, Insufflation, Laparoscopic | 1 | 0 | |
| NMI | Laparoscopic Insufflator And Accessories, Reprocessed | 1 | 0 | 3rd Party |
| OSV | Insufflator, Endoscopic Vessel Harvesting | 2 | 0 | SaMD |
