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 Boston Scientific Corp.

61
Total
61
Cleared
138d
Avg days
1980
Since
61 devices
25–48 of 61
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