Laparoscopic Accessories, Gynecologic

What Is This Device?

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.

How Is NWV Classified?

Laparoscopic Accessories, Gynecologic is FDA product code NWV, Class 1, 21 CFR 884.1720.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 7 recalls under this product code since 2013. None was by a company in China. The root causes the FDA records most often are Packaging process control (1), Nonconforming Material/Component (1) and Labeling design (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.