K232565
- 510(k) number
- K232565
- Device name
- UriSponge
- Applicant
- Copan Italia Spa IT
- Product code
- JSM — Culture Media, Non-Propagating Transport
- Decision date
- 2024-10-11
- Date received
- 2023-08-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
510(k) Summary (official FDA PDF): K232565.pdf
Official FDA record: K232565
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.