LNS · Class II · 21 CFR 876.5990

FDA Product Code LNS: Lithotriptor, Extracorporeal Shock-wave, Urological

Leading manufacturers include Direx Systems Corp., KARL STORZ Endoscopy-America, Inc. and Dornier Medtech America, Inc..

56
Total
56
Cleared
157d
Avg days
2001
Since
56 devices
25–48 of 56
Cleared Mar 01, 2006
INTEGRA
K053640
Direx Systems Corp.
Gastroenterology & Urology · 61d
Cleared Mar 16, 2005
TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE)
K050091
Direx Systems Corp.
Gastroenterology & Urology · 61d
Cleared Dec 03, 2004
GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
K042427
Genemed, Inc.
Gastroenterology & Urology · 86d
Cleared Oct 12, 2004
TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
K042561
Fmd, LLC
Gastroenterology & Urology · 21d
Cleared Aug 26, 2004
STORZ MODULITH, MODEL SLX-F2
K040476
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 184d
Cleared Jul 07, 2004
MODIFICATION TO TRIPTER X-1 COMPACT DUET
K041582
Direx Systems Corp.
Gastroenterology & Urology · 23d
Cleared Apr 28, 2004
TRIPTER X-1 COMPACT
K040470
Direx Systems Corp.
Gastroenterology & Urology · 64d
Cleared Jan 17, 2003
TRIPTER X-1 COMPACT DUET
K023535
Direx Systems Corp.
Gastroenterology & Urology · 88d
Cleared Aug 16, 2002
MODULITH SLK LITHOTRIPTER
K011700
Karl Storz Endoscopy
Gastroenterology & Urology · 441d
Cleared Oct 16, 2001
STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION
K012482
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 75d
Cleared Apr 17, 2001
DORNIER COMPACT ALPHA LITHOTRIPTER
K002929
Dornier Medtech America, Inc.
Gastroenterology & Urology · 209d