Rayvolve
K-Number: K260378 · 2026-05-12
ApplicantAZmed
Decision Date2026-05-12
Product CodeQBS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Rayvolve is a medical device manufactured by AZmed. It received FDA 510(k) clearance on 2026-05-12 under approval number K260378. The device is classified under product code QBS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Rayvolve?
Rayvolve is a medical device that received FDA 510(k) clearance on 2026-05-12. It is manufactured by AZmed. The 510(k) number is K260378.
When was Rayvolve approved by the FDA?
Rayvolve received FDA 510(k) clearance on 2026-05-12, under approval number K260378.
What company makes Rayvolve?
Rayvolve is manufactured by AZmed.
What is the FDA product code for Rayvolve?
The FDA product code for Rayvolve is QBS.
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.