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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lithotriptor, ultrasonic
Regulation Description Extracorporeal shock wave lithotripter.
Product CodeFEO
Regulation Number 876.5990
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 8
Use of Device Issue 7
Device Issue 3
Malfunction 2
Output, low 2
Percutaneous 1
Probe failure 1
Difficult to remove 1
Replace 1
Transducer failure 1
Metal shedding debris 1
Device damaged prior to use 1
Total Device Problems 29

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