Class Class I
UriSponge™ (K232565)
Description
UriSponge™ by Copan Italia Spa, an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK232565
Clearance Date2024-10-11
Clearance TypeTraditional
Product CodeJSM
Regulation Number866.2390
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K232565
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. UriSponge™ (K232565) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K180052 | UriSwab-Urine Collection, Transport and Preservation System | Copan Italia Spa | 2018 |
Trace the full predicate network for K232565
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.