Company · IT
Copan Italia Spa
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2024. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
5recalls (2 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 11, 2024 | K232565 | UriSponge Copan Italia Spa, IT | JSM |
| Apr 25, 2024 | K232357 | Copan Universal Transport Medium (UTM-RT) System Copan Italia Spa, IT | JSM |
| Dec 16, 2022 | K220052 | Copan FecalSwab Collection, Transport and Preservation System Copan Italia Spa, IT | JSM |
| Sep 17, 2020 | K201849 | eNAT molecular collection and preservation medium Copan Italia Spa, IT | QBD |
| Mar 23, 2018 | K180052 | UriSwab-Urine Collection, Transport and Preservation System Copan Italia Spa, IT | JSM |
| Apr 10, 2015 | K142094 | COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM Copan Italia Spa | JSM |
| Aug 20, 1997 | K972449 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL Copan Italia Spa | JSL |
| Aug 20, 1997 | K972448 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL Copan Italia Spa | JSL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2025 | Copan Italia 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk Open, Classified |
PPM | None listed |
| Dec 18, 2025 | Copan Italia 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP*
*Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System Open, Classified |
PPM | None listed |
| Jun 9, 2025 | Copan Italia BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only Open, Classified |
JTW | K993161 |
| Sep 9, 2021 | Copan Italia COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers
REF:501CS01, Minitip, sterile Single Wrapped, Molded bp 80mm;
REF: 20226, P/N 501CS01Q100, Mi Terminated |
KXG | None listed |
| Aug 30, 2013 | Copan Italia WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument
Catalog number: W086
WASP is a fully automated system used to process microbiological specimens in liquid phase for the Terminated |
JTC | None listed |