FDA 510(k)

Rayvolve

K-Number: K260378 · 2026-05-12

ApplicantAZmed

Decision Date2026-05-12

Product CodeQBS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Rayvolve is the device name listed in this FDA 510(k) record. The listed applicant is AZmed. It received FDA 510(k) clearance on 2026-05-12 under 510(k) 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. The listed applicant is AZmed. The 510(k) number is K260378.

When did Rayvolve receive FDA 510(k) clearance?

Rayvolve received FDA 510(k) clearance on 2026-05-12, under 510(k) number K260378.

Who is the listed applicant for Rayvolve?

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

What is the FDA product code for Rayvolve?

The FDA product code for Rayvolve is QBS.

Other records listing AZmed 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.

K243831Rayvolve LN K243808Rayvolve PTX-PE

Related Devices (Code: QBS)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.