NMH

Laparoscope And Accessories, Gynecologic, Reprocessed

Product code

NMH

Device name

Laparoscope And Accessories, Gynecologic, Reprocessed

Device class

Class 2

21 CFR

21 CFR 884.1720

Medical specialty

Obstetrics/Gynecology

Marketing pathway

510(K)

Flag

Third-party review eligible

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).