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FDA 510(k)

Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle

K-Number: K253826 · 2026-05-07

ApplicantGalvanize Therapeutics, Inc.
Decision Date2026-05-07
Product CodeOAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle is a medical device manufactured by Galvanize Therapeutics, Inc.. It received FDA 510(k) clearance on 2026-05-07 under approval number K253826. The device is classified under product code OAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle?

Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle is a medical device that received FDA 510(k) clearance on 2026-05-07. It is manufactured by Galvanize Therapeutics, Inc.. The 510(k) number is K253826.

When was Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle approved by the FDA?

Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle received FDA 510(k) clearance on 2026-05-07, under approval number K253826.

What company makes Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle?

Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle is manufactured by Galvanize Therapeutics, Inc..

What is the FDA product code for Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle?

The FDA product code for Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle is OAB.

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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