NWV — Laparoscopic Accessories, Gynecologic Class I
FDA product code NWV covers "Laparoscopic Accessories, Gynecologic", a Class I medical device regulated under 21 CFR 884.1720. Submissions are reviewed by the Obstetrics/Gynecology panel.
Classification Details
- Product Code
- NWV
- Device Class
- Class I
- Regulation Number
- 884.1720
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
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.