NWV

Laparoscopic Accessories, Gynecologic

Product code

NWV

Device name

Laparoscopic Accessories, Gynecologic

Device class

Class 1

21 CFR

21 CFR 884.1720

Medical specialty

Obstetrics/Gynecology

Marketing pathway

510(K) Exempt

FDA classification definition

Exempt laparoscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).