Cleared Traditional

UriSponge?

K232565 · Copan Italia Spa · Microbiology
Oct 2024
Decision
414d
Days
Class 1
Risk

About This 510(k) Submission

K232565 is an FDA 510(k) clearance for the UriSponge?, a Culture Media, Non-propagating Transport (Class I — General Controls, product code JSM), submitted by Copan Italia Spa (Brescia, IT). The FDA issued a Cleared decision on October 11, 2024, 414 days after receiving the submission on August 24, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K232565 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 2023
Decision Date October 11, 2024
Days to Decision 414 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JSM — Culture Media, Non-propagating Transport
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2390

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