Revi System
K-Number: K252391 · 2025-12-12
ApplicantBluewind Medical , Ltd.
Decision Date2025-12-12
Product CodeQXM
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Revi System is a medical device manufactured by Bluewind Medical , Ltd.. It received FDA 510(k) clearance on 2025-12-12 under approval number K252391. The device is classified under product code QXM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Revi System?
Revi System is a medical device that received FDA 510(k) clearance on 2025-12-12. It is manufactured by Bluewind Medical , Ltd.. The 510(k) number is K252391.
When was Revi System approved by the FDA?
Revi System received FDA 510(k) clearance on 2025-12-12, under approval number K252391.
What company makes Revi System?
Revi System is manufactured by Bluewind Medical , Ltd..
What is the FDA product code for Revi System?
The FDA product code for Revi System is QXM.
Other Devices by Bluewind Medical , Ltd.
Related Devices (Code: QXM)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.