NWW · Class I — Low Risk (general controls) · Obstetrics/Gynecology · 21 CFR 884.1690
Classification
FDA Product Code
NWW
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 884.1690
Review panel
OB
Medical specialty
Obstetrics/Gynecology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.