FDA Product Code FGA: Kit, Nephroscope
Leading manufacturers include KARL STORZ Endoscopy-America, Inc. and Karl Storz SE & CO. KG.
10
Total
10
Cleared
137d
Avg days
1977
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Kit, Nephroscope Devices (Product Code FGA)
10 devices
Cleared
May 01, 2024
Percutaneous Nephroscope System
Karl Storz SE & CO. KG
Gastroenterology & Urology
267d
Cleared
Mar 15, 1995
KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology
41d
Cleared
Sep 09, 1994
KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology
212d
About Product Code FGA - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code FGA since 1977, with 10 receiving FDA clearance (average review time: 137 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.