21 CFR 884.1720 — Laparoscope, Gynecologic (And Accessories)
Obstetrics/Gynecology (OB) · Part 884 Subpart B—Obstetrical and Gynecological Diagnostic Devices · § 884.1720
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | 2 | 338 | |
| NMH | Laparoscope And Accessories, Gynecologic, Reprocessed | 2 | 0 | 3rd Party |
| NWV | Laparoscopic Accessories, Gynecologic | 1 | 0 | |
| OCQ | Laparoscopic Bladder-Neck Suspension Instrument, Stress Urinary Incontinence | 2 | 0 | 3rd Party |
| OHD | Gynecological Laparoscopic Kit | 2 | 0 | |
| OHM | Cesarean Section Tray | 2 | 0 | |
| OKX | Trocar Kit | 2 | 0 |
