FJS · Class II · 21 CFR 876.5630

FDA Product Code FJS: Catheter, Peritoneal, Long-term Indwelling

Leading manufacturers include Covidien, LLC.

48
Total
48
Cleared
139d
Avg days
1977
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Catheter, Peritoneal, Long-term Indwelling Devices (Product Code FJS)

48 devices
1–24 of 48

About Product Code FJS - Regulatory Context

510(k) Submission Activity

48 total 510(k) submissions under product code FJS since 1977, with 48 receiving FDA clearance (average review time: 139 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

FJS devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →