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
49–61 of 61
Cleared Jun 01, 1989
MDL-1 LASERTRIPTER(TM)
K885255
Candela Laser Corp.
Gastroenterology & Urology · 160d
Cleared Mar 23, 1989
TECHNOMED PULSOLITH LASER SYSTEM
K890436
Teknomed, Inc.
Gastroenterology & Urology · 55d
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 Feb 10, 1987
3F ELECTRODE
K864904
Northgate Research, Inc.
Gastroenterology & Urology · 57d
Cleared Dec 03, 1986
CANDELA MODEL MDL-1 LASER LITHOTRIPTOR
K863642
Candela Corp.
Gastroenterology & Urology · 77d
Cleared Aug 21, 1985
5F ELECTRODE(LITHOTRIPTOR)
K852874
Northgate Research, Inc.
Gastroenterology & Urology · 44d
Cleared May 25, 1984
LITHOTRIPTOR ELECTRODE 4.5F
K834228
Monaghan Medical Corp.
Gastroenterology & Urology · 171d
Cleared Nov 28, 1983
COAXIAL ELECTRODE #300A
K832566
K-Med, Inc.
Gastroenterology & Urology · 118d
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
Cleared Sep 21, 1982
RIWOLITH 2135
K822644
R. Wolf Medical Instruments Corp.
Gastroenterology & Urology · 20d
Cleared Nov 10, 1980
MODEL SD-1 DISINTEGRATOR
K802322
Northgate Research, Inc.
Gastroenterology & Urology · 48d