• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device lithotriptor, ultrasonic
Regulation Description Electrohydraulic lithotriptor.
Product CodeFEO
Regulation Number 876.4480
Device Class 2


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

Device Problems
Break 20
Use of Device Issue 10
Difficult to remove 8
Material separation 3
Device Issue 3
Malfunction 2
Output, low 2
Percutaneous 1
Probe failure 1
Material fragmentation 1
Transducer failure 1
Replace 1
Failure to separate 1
No Known Device Problem 1
Metal shedding debris 1
Improper or incorrect procedure or method 1
Device damaged prior to use 1
Total Device Problems 58

-
-