Class Class II

Revi System (K252391)

K252391 2025-12-12 Traditional
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Description

Revi System by Bluewind Medical , Ltd., an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK252391
Clearance Date2025-12-12
Clearance TypeTraditional
Product CodeQXM
Regulation Number876.5305

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