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FDA 510(k)

Genadyne ASTRA NPWT

K-Number: K253429 · 2026-03-12

ApplicantGenadyne Biotechnologies, Inc.
Decision Date2026-03-12
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Genadyne ASTRA NPWT is the device name listed in this FDA 510(k) record. The listed applicant is Genadyne Biotechnologies, Inc.. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K253429. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Genadyne ASTRA NPWT?

Genadyne ASTRA NPWT is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Genadyne Biotechnologies, Inc.. The 510(k) number is K253429.

When did Genadyne ASTRA NPWT receive FDA 510(k) clearance?

Genadyne ASTRA NPWT received FDA 510(k) clearance on 2026-03-12, under 510(k) number K253429.

Who is the listed applicant for Genadyne ASTRA NPWT?

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

What is the FDA product code for Genadyne ASTRA NPWT?

The FDA product code for Genadyne ASTRA NPWT is OMP.

Other records listing Genadyne Biotechnologies, Inc. as applicant

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Related Devices (Code: OMP)

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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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