K232565 is an FDA 510(k) clearance for the UriSponge™. This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.2390.
| 510(k) Number | K232565 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | JSM - Culture Media, Non-propagating Transport |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2390 |