Laparoscope And Accessories, Gynecologic, Reprocessed
Medical specialty
Obstetrics/Gynecology
Device class
2
Regulation number
884.1720
Review panel
OB
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Ineligible
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).