• 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 coagulator, laparoscopic, unipolar (and accessories)
510(k) Number K121858
Device Name THE ABLATION SYSTEM
Original Applicant
HALT MEDICAL INC.
131 sand creek road, suite b
brentwood,  CA  94513
Original Contact clarisa tate
Regulation Number884.4160
Classification Product Code
HFG  
Date Received06/26/2012
Decision Date 11/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Clinical Trials NCT00874029
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-