Class Class I

Modius Lean (DEN240076)

DEN240076 2025-10-17 Direct
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Description

Modius Lean by Neurovalens Limited, an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class I
510(k) NumberDEN240076
Clearance Date2025-10-17
Clearance TypeDirect
Product CodeSFW
Regulation Number876.5984

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