NMH — Laparoscope And Accessories, Gynecologic, Reprocessed Class II
FDA product code NMH covers "Laparoscope And Accessories, Gynecologic, Reprocessed", a Class II medical device regulated under 21 CFR 884.1720. Submissions are reviewed by the Obstetrics/Gynecology panel.
Classification Details
- Product Code
- NMH
- Device Class
- Class II
- Regulation Number
- 884.1720
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Definition
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. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).