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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Non-Propagating Transport
510(k) Number K232565
Device Name UriSponge™
Applicant
Copan Italia Spa
Via Francesco Perotti 10
Brescia,  IT 25125
Applicant Contact Silvia Caprini
Correspondent
Copan Italia Spa
Via Francesco Perotti 10
Brescia,  IT 25125
Correspondent Contact Silvia Caprini
Regulation Number866.2390
Classification Product Code
JSM  
Subsequent Product Code
LIO  
Date Received08/24/2023
Decision Date 10/11/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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