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 cannula, manipulator/injector, uterine
510(k) Number K160217
Device Name uVue HSG/SHG Catheter
Applicant
COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON,  IN  47404
Applicant Contact Kara Kanorr
Correspondent
COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON,  IN  47404
Correspondent Contact Kara Kanorr
Regulation Number884.4530
Classification Product Code
LKF  
Date Received01/29/2016
Decision Date 10/06/2016
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
-
-