FDA Product Code LJE: Catheter, Nephrostomy
Leading manufacturers include Coloplast Corp. and Shenzhen Trious Medical Technology Co., Ltd..
56
Total
56
Cleared
129d
Avg days
1982
Since
Stable submission activity - 1 submissions in the last 2 years
Consistent review times:
135d avg (recent)
FDA 510(k) Cleared Catheter, Nephrostomy Devices (Product Code LJE)
56 devices
Cleared
Jul 03, 2025
Disposable Percutaneous Nephrostomy Dilatation Kit
Shenzhen Trious Medical Technology Co., Ltd.
Gastroenterology & Urology
135d
Cleared
Mar 10, 2022
Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
Coloplast Corp.
Gastroenterology & Urology
262d
About Product Code LJE - Regulatory Context
510(k) Submission Activity
56 total 510(k) submissions under product code LJE since 1982, with 56 receiving FDA clearance (average review time: 129 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
FDA review times for LJE submissions have been consistent, averaging 135 days recently vs 129 days historically.
LJE devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →