Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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


New Search Back To Search Results
Device Classification Name lithotriptor, electro-hydraulic
510(K) Number K120303
Model CW-USLSA
Device Name CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM
Applicant
CYBERSONICS, INC.
5325 kuhl rd.
erie,  PA  16510
Contact lori colvin
Regulation Number876.4480
Classification Product Code
FFK  
Date Received02/13/2012
Decision Date 06/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-