FDA Product Code GCJ: Laparoscope, General & Plastic Surgery

Laparoscopic surgery has transformed general and plastic surgery by enabling minimally invasive procedures through small incisions. FDA product code GCJ covers laparoscopes used in these procedures.

These optical instruments allow surgeons to visualize the abdominal and pelvic cavity via a small camera inserted through a trocar. They are used in cholecystectomy, appendectomy, hernia repair, and bariatric surgery.

GCJ devices are Class II medical devices, regulated under 21 CFR 876.1500 and reviewed by the FDA General & Plastic Surgery panel. Reusable devices require validated reprocessing instructions.

Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Origin Medsystems, Inc. and Phx Technologies Corp..