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 Dec 26, 2007
STORZ MODULITH LITHOTRIPTER SLX-F2-F180
K072788
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 86d
Cleared Nov 01, 2007
MODULARIS VARIOSTAR
K070799
Siemens Medical Solutions USA, Inc.
Gastroenterology & Urology · 223d
Cleared Aug 30, 2007
STORZ SLX-F2 STORM TOUCH
K070579
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 182d
Cleared Mar 09, 2007
ECONOLITH EM1000
K063504
Medispec, Ltd.
Gastroenterology & Urology · 109d
Cleared Dec 22, 2006
LITHODIAMOND ULTRA
K061350
Pck Electronic Industry & Trade Co., Ltd.
Gastroenterology & Urology · 221d
Cleared Nov 02, 2006
LITHOGOLD
K062081
Tissue Regeneration Technologies, Inc.
Gastroenterology & Urology · 104d
Cleared Oct 20, 2006
INTEGRA SL
K062147
Direx Systems Corp.
Gastroenterology & Urology · 85d
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 Aug 19, 2004
ULTRASOUND LOCALIZATION SYSTEM ULS 0142
K040741
Hmt High Medical Technologies AG
Gastroenterology & Urology · 149d
Cleared Jul 07, 2004
MODIFICATION TO TRIPTER X-1 COMPACT DUET
K041582
Direx Systems Corp.
Gastroenterology & Urology · 23d
Cleared May 25, 2004
ECONOLITH E3000, MODEL 3000 (SW-6)
K040461
Medispec, Ltd.
Gastroenterology & Urology · 92d
Cleared Apr 28, 2004
TRIPTER X-1 COMPACT
K040470
Direx Systems Corp.
Gastroenterology & Urology · 64d
Cleared Feb 17, 2004
PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000
K032958
United Medical Systems, Inc.
Gastroenterology & Urology · 148d
Cleared May 02, 2003
TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
K030346
Fmd, LLC
Gastroenterology & Urology · 88d
Cleared Jan 17, 2003
TRIPTER X-1 COMPACT DUET
K023535
Direx Systems Corp.
Gastroenterology & Urology · 88d
Cleared Dec 23, 2002
LTFS230
K021775
Healthtronics, Inc.
Gastroenterology & Urology · 208d
Cleared Aug 16, 2002
MODULITH SLK LITHOTRIPTER
K011700
Karl Storz Endoscopy
Gastroenterology & Urology · 441d
Cleared Apr 29, 2002
DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER
K013471
E.S.W.L. Products, Inc.
Gastroenterology & Urology · 193d
Cleared Feb 11, 2002
STONELITH, MODEL V5
K011106
Pck Electronic Industry and Trade Co, Ltd.
Gastroenterology & Urology · 306d
Cleared Nov 16, 2001
TWINTRODE ELC 134 ELECTRODE
K012785
Healthtronics Surgical Services, Inc.
Gastroenterology & Urology · 88d