• 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 tubes, gastrointestinal (and accessories)
510(k) Number K121571
Model MODEL 101
Device Name TUBECLEAR
Original Applicant
ACTUATED MEDICAL, INC
310 rolling ridge dr
bellefonte,  PA  16823
Original Contact debora demers
Regulation Number876.5980
Classification Product Code
KNT  
Date Received05/29/2012
Decision Date 06/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
-
-