Revi System
K-Number: K253651 · 2026-07-28
Device Summary
Frequently Asked Questions
What is the Revi System?
Revi System is a medical device that received FDA 510(k) clearance on 2026-07-28. The listed applicant is Bluewind Medical , Ltd.. The 510(k) number is K253651.
When did Revi System receive FDA 510(k) clearance?
Revi System received FDA 510(k) clearance on 2026-07-28, under 510(k) number K253651.
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.
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.
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.
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.