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510(k) Data Aggregation
K Number
K033335Device Name
LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS
Manufacturer
Date Cleared
2003-11-25
(40 days)
Product Code
Regulation Number
876.4890Why did this record match?
Product Code :
MMZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
LITHOSTAR Modularis with Shockwave System Coplis is a urologic procedures system which can be used for a wide range of applications. It is a transportable system. The system is capable of both diagnostic and therapeutic procedures of urolithiasis in the kidney and upper ureter. The primary use of this device is for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvis stones, and upper ureteral stones by extracorporeal shock wave lithotripsy (ESWL). In addition to ESWL use, the unit is designed for patient placement in positions which facilitate urological and diagnostic procedures.
Device Description
Siemens LITHOSTAR MODULARIS with Shockwave System Collis is a modification to our predicate device. The shockwave head has been modified to provide an increased penetration depth for a more obese patient population. The penetration depth has been increased from 120mm to 140mm..
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