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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intrauterine Tamponade Balloon
510(k) Number K253642
Device Name Jada System (Jada-2002)
Applicant
Organon, LLC
30 Hudson St.
Floor 33
Jersey City,  NJ  07302
Applicant Contact Riddhish Patel
Correspondent
Organon, LLC
30 Hudson St.
Floor 33
Jersey City,  NJ  07302
Correspondent Contact Riddhish Patel
Regulation Number884.4530
Classification Product Code
OQY  
Date Received11/19/2025
Decision Date 05/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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