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) | 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 Classification Name culdoscope (and accessories)
510(k) Number K161065
Device Name ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator
Applicant
Surgitools Pty Ltd.
231 Timberlane Dr.
Woodvale,  AU 6026
Applicant Contact Jai Singh
Correspondent
Emergo Global Consulting, LLC
816 Congress Avenue, Suite 1400
Austin,  TX  78701
Correspondent Contact Elizabeth Pugh
Regulation Number884.1640
Classification Product Code
HEW  
Date Received04/15/2016
Decision Date 10/27/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-