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 Stryker, Stryker Endoscopy and Guangdong Optomedic Technologies, Inc..
FDA 510(k) Cleared Laparoscope, General & Plastic Surgery Devices (Product Code GCJ)
About Product Code GCJ - Regulatory Context
510(k) Submission Activity
1415 total 510(k) submissions under product code GCJ since 1977, with 1415 receiving FDA clearance (average review time: 114 days).
Submission volume has remained relatively stable over the observed period, with 52 submissions in the last 24 months.
FDA Review Time
FDA review times for GCJ submissions have been consistent, averaging 126 days recently vs 114 days historically.
GCJ devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →