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FDA 510(k)

Volnewmer™

K-Number: K253504 · 2026-07-13

ApplicantClassys, Inc.
Decision Date2026-07-13
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Volnewmer™ is the device name listed in this FDA 510(k) record. The listed applicant is Classys, Inc.. It received FDA 510(k) clearance on 2026-07-13 under 510(k) number K253504. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Volnewmer™?

Volnewmer™ is a medical device that received FDA 510(k) clearance on 2026-07-13. The listed applicant is Classys, Inc.. The 510(k) number is K253504.

When did Volnewmer™ receive FDA 510(k) clearance?

Volnewmer™ received FDA 510(k) clearance on 2026-07-13, under 510(k) number K253504.

Who is the listed applicant for Volnewmer™?

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

What is the FDA product code for Volnewmer™?

The FDA product code for Volnewmer™ is GEI.

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Other records listing Classys, Inc. as applicant

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Related Devices (Code: GEI)

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.

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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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