Modius Lean
FDA 510(k) clearance DEN240076 · decided 2025-10-17
Clearance details
- K-number
- DEN240076
- Device name
- Modius Lean
- Applicant
- Neurovalens Limited
- Decision
- Unknown
- Date received
- 2024-12-18
- Decision date
- 2025-10-17
- Days to decision
- 303 days
- Clearance type
- Direct
- Product code
- SFW
- Device class
- 1
- Regulation number
- 876.5984
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- 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.