• 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 | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K122203
Models M00574151,M00584161,M00584171,M00584181, M00584150,M00584160,M00584170,00584180, M00584172,M00584182,M00584192,M00584122, M00584190,M00584120, M00584191,M00584121,M00584152,M00584162
Device Name TRUETOME
Original Applicant
BOSTON SCIENTIFIC CORP.
100 boston scientific way
marlborough,  MA  01752
Original Contact laurie pannella
Regulation Number876.4300
Classification Product Code
KNS  
Date Received07/25/2012
Decision Date 08/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-