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 Tenaculum, Uterine
510(k) Number K223866
Device Name Carevix™ Suction Cervical Stabilizer
Applicant
Aspivix SA
Chemin du Closel, 5
Renens,  CH 1020
Applicant Contact Mauro Rinaldi
Correspondent
Aspivix SA
Chemin du Closel, 5
Renens,  CH 1020
Correspondent Contact Mauro Rinaldi
Regulation Number884.4530
Classification Product Code
HDC  
Date Received12/23/2022
Decision Date 01/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-