FFK · Class II · 21 CFR 876.4480

FDA Product Code FFK: Lithotriptor, Electro-hydraulic

Leading manufacturers include Northgate Technologies, Inc., Richard Wolf Medical Instruments Corp. and Cybersonics, Inc..

61
Total
61
Cleared
138d
Avg days
1980
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 177d recently vs 137d historically

FDA 510(k) Cleared Lithotriptor, Electro-hydraulic Devices (Product Code FFK)

61 devices
1–24 of 61
Cleared Mar 21, 2025
Electrohydraulic Lithotriptor (TCS-B3-II)
K242888
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Gastroenterology & Urology · 179d
Cleared Mar 21, 2025
EHL Probe (SCDG-AS)
K243032
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Gastroenterology & Urology · 175d
Cleared Aug 31, 2023
EL27-Compact
K230488
Walz Elektronik GmbH
Gastroenterology & Urology · 189d
Cleared Jun 14, 2021
URO-TOUCH 9 French Probe
K202813
Northgate Technologies, Inc.
Gastroenterology & Urology · 263d
Cleared May 29, 2019
Swiss LithoClast Trilogy
K191124
E.M.S Electro Medical Systems S.A
Gastroenterology & Urology · 30d
Cleared Aug 29, 2016
UreTron PF Series Probe
K162119
Med-Sonics Corp.
Gastroenterology & Urology · 28d
Cleared Feb 23, 2016
UreTron MultiProbe Lithotripter System
K160198
Med-Sonics Corp.
Gastroenterology & Urology · 26d
Cleared Nov 26, 2013
CYBERWAND STERILE PROBE SET
K132795
Cybersonics, Inc.
Gastroenterology & Urology · 81d
Cleared Nov 15, 2013
AUTOLITH TOUCH
K130368
Northgate Technologies, Inc.
Gastroenterology & Urology · 274d
Cleared Jan 16, 2013
SWISS LITHOBREAKER
K123038
E.M.S Electro Medical Systems S.A
Gastroenterology & Urology · 110d
Cleared Jun 05, 2012
CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM
K120303
Cybersonics, Inc.
Gastroenterology & Urology · 125d
Cleared Mar 30, 2012
URETRON MODEL URT
K111058
Med-Sonics Corp.
Gastroenterology & Urology · 347d
Cleared Dec 20, 2005
CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER
K052135
Cybersonics, Inc.
Gastroenterology & Urology · 137d
Cleared Sep 17, 2001
SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX
K011911
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 90d
Cleared May 09, 2001
INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO)
K011065
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 30d
Cleared Jul 19, 2000
MICROVASIVE LITHOTRIPTOR FLEXPROBE II
K002084
Boston Scientific Corp
Gastroenterology & Urology · 9d
Cleared Aug 18, 1999
KSEA CALCUSPLIT
K992114
Karl Storz Endoscopy
Gastroenterology & Urology · 57d
Cleared Jul 27, 1999
SWISS LITHOCLAST MULTIPURPOSE PROBE
K992251
Electro Medical Systems SA
Gastroenterology & Urology · 21d
Cleared Jul 14, 1999
ELECTRO MECHANICAL LITHOTRIPTOR
K990341
Northgate Technologies, Inc.
Gastroenterology & Urology · 161d
Cleared Nov 17, 1998
AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)
K980492
Circon Acmi
Gastroenterology & Urology · 281d
Cleared Jun 15, 1998
KSEA CALCUSPLIT
K981233
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 73d
Cleared Mar 12, 1998
LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER
K974796
Medispec, Ltd.
Gastroenterology & Urology · 80d
Cleared Jan 21, 1998
MICROVASIVE LIPTHOTRIPSY PROBES
K973788
Boston Scientific Corp
Gastroenterology & Urology · 107d
Cleared Dec 18, 1997
SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE
K974164
Medical Device Consultants, Inc.
Gastroenterology & Urology · 43d

About Product Code FFK - Regulatory Context

510(k) Submission Activity

61 total 510(k) submissions under product code FFK since 1980, with 61 receiving FDA clearance (average review time: 138 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - FFK Product Code

Recent submissions under FFK have taken an average of 177 days to reach a decision - up from 137 days historically. Manufacturers should account for longer review timelines in current project planning.

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