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FDA 510(k)

Revi™ System

K-Number: K240037 · 2024-05-02

ApplicantBluewind Medical , Ltd.
Decision Date2024-05-02
Product CodeQXM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Revi™ System is the device name listed in this FDA 510(k) record. The listed applicant is Bluewind Medical , Ltd.. It received FDA 510(k) clearance on 2024-05-02 under 510(k) number K240037. 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 2024-05-02. The listed applicant is Bluewind Medical , Ltd.. The 510(k) number is K240037.

When did Revi™ System receive FDA 510(k) clearance?

Revi™ System received FDA 510(k) clearance on 2024-05-02, under 510(k) number K240037.

Who is the listed applicant for Revi™ System?

The FDA 510(k) record lists Bluewind Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Revi™ System?

The FDA product code for Revi™ System is QXM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06217328RESTORE: An RCT to Evaluate the Efficacy of the Revi SystemACTIVE_NOT_RECRUITING

Other records listing Bluewind Medical , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253651Revi SystemK252391Revi System

Related Devices (Code: QXM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253651Revi SystemBluewind Medical , Ltd.K252391Revi SystemBluewind Medical , Ltd.

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.

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