Laparoscopic Accessories, Gynecologic
The Laparoscopic Accessories, Gynecologic (product code NWV) encompasses non-powered, non-inflatable manual mechanical accessories used with gynecologic laparoscopes, including cannulas, graspers, forceps, dissectors, and scissors, intended for diagnostic and surgical procedures on the female genital organs. It is classified as FDA Class 1, subject to general controls and exempt from 510(k) premarket notification requirements, regulated under 21 CFR 884.1720 within the Obstetrics/Gynecology specialty. The device has no implant or life-sustaining designations.
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Basic Information
- Product Code
- NWV
- Device Class
- FDA class 1
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 79 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 79 registration numbers. Click on an entry to view related FDA registrations.