FDA Product Code FJL: Resectoscope
Leading manufacturers include KARL STORZ Endoscopy-America, Inc. and Karl Storz SE & CO. KG.
24
Total
24
Cleared
121d
Avg days
1976
Since
Declining activity -
0 submissions in the last 2 years
vs 3 in the prior period
FDA 510(k) Cleared Resectoscope Devices (Product Code FJL)
24 devices
Cleared
May 07, 2024
KARL STORZ Monopolar Resectoscopes with HF Cable
Karl Storz SE & CO. KG
Gastroenterology & Urology
265d
Cleared
Mar 17, 2023
KARL STORZ Bipolar Resectoscopes with HF Cable
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology
261d
About Product Code FJL - Regulatory Context
510(k) Submission Activity
24 total 510(k) submissions under product code FJL since 1976, with 24 receiving FDA clearance (average review time: 121 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.
FJL devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →