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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tenaculum, uterine
510(k) Number K223866
Device Name Carevix™ Suction Cervical Stabilizer
Aspivix SA
Chemin du Closel, 5
Renens,  CH 1020
Applicant Contact Mauro Rinaldi
Aspivix SA
Chemin du Closel, 5
Renens,  CH 1020
Correspondent Contact Mauro Rinaldi
Regulation Number884.4530
Classification Product Code
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