Clearance Summary
Modius Lean received FDA 510(k) clearance under submission number DEN240076, sponsored by Neurovalens Limited. The device was reviewed via the Direct premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2025-10-17.
- Submission: DEN240076
- Applicant / Sponsor: Neurovalens Limited
- Clearance pathway: Direct
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5984
- Decision date: 2025-10-17
Classification & Regulation
This clearance is catalogued under FDA product code SFW and 21 CFR 876.5984, within the Gastroenterology, Urology review panel as a Class I device.