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 K220202
Device Name Uterine ElevatOR PRO with OccludOR Balloon
Applicant
The O R Company Pty, Ltd.
1/32 Silkwood Rise
Carrum Downs,  AU 3201
Applicant Contact Nicole Conway
Correspondent
The O R Company Pty, Ltd.
1/32 Silkwood Rise
Carrum Downs,  AU 3201
Correspondent Contact Nicole Conway
Regulation Number884.4530
Classification Product Code
LKF  
Date Received01/24/2022
Decision Date 03/31/2022
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
Predetermined Change
Control Plan Authorized		 No
-
-