NWW — Hysteroscope Accessories Class I
FDA product code NWW covers "Hysteroscope Accessories", a Class I medical device regulated under 21 CFR 884.1690. Submissions are reviewed by the Obstetrics/Gynecology panel.
Classification Details
- Product Code
- NWW
- Device Class
- Class I
- Regulation Number
- 884.1690
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
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.