NWW

Hysteroscope Accessories

Product code

NWW

Device name

Hysteroscope Accessories

Device class

Class 1

21 CFR

21 CFR 884.1690

Medical specialty

Obstetrics/Gynecology

Marketing pathway

510(K) Exempt

FDA classification definition

Exempt hysteroscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

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