FGA · Class II · 21 CFR 876.1500

FDA Product Code FGA: Kit, Nephroscope

Leading manufacturers include Richard Wolf Medical Instruments Corp., KARL STORZ Endoscopy-America, Inc. and Gyrus Acmi, Inc..

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
1–10 of 10
Cleared May 01, 2024
Percutaneous Nephroscope System
K232370
Karl Storz SE & CO. KG
Gastroenterology & Urology · 267d
Cleared Dec 13, 2007
GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM
K072594
Gyrus Acmi, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 05, 2000
NEPHROSCOPE, 12 DEGREES
K994223
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 173d
Cleared Mar 15, 1995
KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES
K950433
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 41d
Cleared Sep 09, 1994
KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE
K940594
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 212d
Cleared Sep 12, 1985
OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE
K853486
Olympus Corp.
Gastroenterology & Urology · 23d
Cleared Apr 28, 1977
PYELOSCOPE SYSTEM
K770729
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 8d

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.