Modius Spero
FDA 510(k) clearance DEN250013 · decided 2026-05-08
Clearance details
- K-number
- DEN250013
- Device name
- Modius Spero
- Applicant
- Neurovalens Limited
- Decision
- Unknown
- Date received
- 2025-04-16
- Decision date
- 2026-05-08
- Days to decision
- 387 days
- Clearance type
- Direct
- Product code
- SHX
- Device class
- 2
- Regulation number
- 882.5807
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Portglenone, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.