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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 a medical device manufactured by Genadyne Biotechnologies, Inc.. It received FDA 510(k) clearance on 2026-03-12 under approval 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. It is manufactured by Genadyne Biotechnologies, Inc.. The 510(k) number is K253429.

When was Genadyne ASTRA NPWT approved by the FDA?

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

What company makes Genadyne ASTRA NPWT?

Genadyne ASTRA NPWT is manufactured by Genadyne Biotechnologies, Inc..

What is the FDA product code for Genadyne ASTRA NPWT?

The FDA product code for Genadyne ASTRA NPWT is OMP.

Other Devices by Genadyne Biotechnologies, Inc.

K161599UNO Negative Pressure Wound Therapy System K180840UNO Negative Pressure Wound Therapy System K221891UNO Negative Pressure Wound Therapy System K210107Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System K221888Genadyne Hybrid Foam Dressings K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)

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Related Devices (Code: OMP)

K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemKci USA, Inc. K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power SupplyMedela AG K150960WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC

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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