Data / Medical devices / Italy / WISE S.p.A.
WISE S.p.A.: FDA-registered device maker in Cologno Monzese Lombardy, Italy, 1 510(k) clearance
WISE S.p.A. is registered with the FDA (registration 3030387292) in Cologno Monzese Lombardy, Italy. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 22, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030387292
- Address
- Via Michelangelo Buonarroti 38, Cologno Monzese Lombardy, Italy, 20093
- Owner or operator
- WISE S.p.A (10089558)
- Roles
- Manufacturer
- First device listed
- December 18, 2023
- Registered through
- 2026
- Brand names listed
- WCS Link (WSCC_4CH), WCS Link (WSCC_4CH-001), WISE Cortical Strip
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Cortical | GYC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 22, 2022 | K221123 | WISE Cortical Strip (WCS) | GYC | Substantially Equivalent | Wise S.R.L. | accessdata.fda.gov |
Compare with other makers
Updated November 22, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.