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
61 devices
25–48 of 61
Cleared Feb 13, 1997
EMS SWISS LITHOCLAST LITHOTRIPTER
K963285
Electro Medical Systems SA
Gastroenterology & Urology · 176d
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 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 01, 1989
MDL-1 LASERTRIPTER(TM)
K885255
Candela Laser Corp.
Gastroenterology & Urology · 160d
Cleared Feb 13, 1989
MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS
K883189
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 200d
Cleared Jun 17, 1988
MDL-1 LASERTRIPTER
K880503
Candela Laser Corp.
Gastroenterology & Urology · 130d
Cleared Dec 03, 1986
CANDELA MODEL MDL-1 LASER LITHOTRIPTOR
K863642
Candela Corp.
Gastroenterology & Urology · 77d
Cleared May 25, 1984
LITHOTRIPTOR ELECTRODE 4.5F
K834228
Monaghan Medical Corp.
Gastroenterology & Urology · 171d
Cleared Feb 09, 1983
4.5 F LITHOTRIPTOR ELECTRODE
K830086
Monaghan Medical Corp.
Gastroenterology & Urology · 29d
Cleared Sep 28, 1982
LITHOTRIPTOR ELECTRODE 4.5F
K822585
Monaghan Medical Corp.
Gastroenterology & Urology · 33d