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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Personal
510(k) Number K260007
Device Name Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg)
Applicant
Hudi Pharma Srl
Piazza Giuseppe Grandi 19
Milano,  IT 20129
Applicant Contact Marco Mattielli
Correspondent
Hudi Pharma Srl
Piazza Giuseppe Grandi 19
Milano,  IT 20129
Correspondent Contact Marco Mattielli
Regulation Number884.5300
Classification Product Code
NUC  
Date Received01/02/2026
Decision Date 04/01/2026
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
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