FFK · Class II · 21 CFR 876.4480

FDA Product Code FFK: Lithotriptor, Electro-hydraulic

Leading manufacturers include Northgate Technologies, Inc., Cybersonics, Inc. and Northgate Research, Inc..

61
Total
61
Cleared
138d
Avg days
1980
Since
61 devices
25–48 of 61
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
Cleared Feb 13, 1997
EMS SWISS LITHOCLAST LITHOTRIPTER
K963285
Electro Medical Systems SA
Gastroenterology & Urology · 176d
Cleared Aug 24, 1995
SWISS LITHOCLAST LITHOTRIPTER
K951531
Electro Medical Systems SA
Gastroenterology & Urology · 143d
Cleared Mar 17, 1995
PULSE GUARD 3FR ELECTRODE
K944571
Northgate Technologies, Inc.
Gastroenterology & Urology · 179d
Cleared Apr 15, 1994
RIWOLITH 2280 PROBES
K931755
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 372d
Cleared Feb 15, 1994
EHL PULSE GENERATOR
K931779
Psi Medical Products, Inc.
Gastroenterology & Urology · 312d
Cleared Feb 14, 1994
EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB
K920410
Psi Medical Products, Inc.
Gastroenterology & Urology · 745d
Cleared Jul 30, 1993
PULSE GUARD ELECTRODE
K925396
Northgate Technologies, Inc.
Gastroenterology & Urology · 277d
Cleared Jan 28, 1993
AUTOLITH-IEHL
K923822
Northgate Technologies, Inc.
Gastroenterology & Urology · 182d
Cleared Jun 30, 1992
SD-200IEHL(TM)
K914517
Northgate Technologies, Inc.
Gastroenterology & Urology · 265d
Cleared Feb 05, 1992
RIWOLITH 2280
K913487
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 183d
Cleared Jan 07, 1992
3 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
K914515
Northgate Technologies, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 07, 1992
9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
K914516
Northgate Technologies, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 06, 1992
1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
K914514
Northgate Technologies, Inc.
Gastroenterology & Urology · 89d
Cleared Nov 29, 1991
1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
K913955
Northgate Technologies, Inc.
Gastroenterology & Urology · 85d
Cleared Jun 04, 1991
LITHOTRIPTOR SYSTEM MODEL 27080
K905553
Karl Storz GmbH & Co. (Kst)
Gastroenterology & Urology · 175d
Cleared Nov 16, 1990
1.9 FRENCH LITHOTRIPTER ELECTRODE
K903337
Northgate Research, Inc.
Gastroenterology & Urology · 114d
Cleared Oct 18, 1989
2.5 FRENCH LITHOTRIPTOR ELECTRODE
K894704
Northgate Research, Inc.
Gastroenterology & Urology · 85d
Cleared Oct 06, 1989
TECHNOMED PULSOLITH LASER SYSTEM
K895178
Teknomed, Inc.
Gastroenterology & Urology · 57d