NWV · Laparoscopic Accessories, Gynecologic
Obstetrics/Gynecology · 21 CFR 884.1720 · Class 1
Overview
| Product Code | NWV |
|---|---|
| Device Name | Laparoscopic Accessories, Gynecologic |
| Regulation | 21 CFR 884.1720 |
| Device Class | Class 1 |
| Review Panel | Obstetrics/Gynecology |
Identification
A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.
Classification Rationale
(1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
