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FDA 510(k)

Genadyne Hybrid Foam Dressings

K-Number: K221888 · 2023-06-12

ApplicantGenadyne Biotechnologies, Inc.
Decision Date2023-06-12
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Genadyne Hybrid Foam Dressings is a medical device manufactured by Genadyne Biotechnologies, Inc.. It received FDA 510(k) clearance on 2023-06-12 under approval number K221888. 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 Hybrid Foam Dressings?

Genadyne Hybrid Foam Dressings is a medical device that received FDA 510(k) clearance on 2023-06-12. It is manufactured by Genadyne Biotechnologies, Inc.. The 510(k) number is K221888.

When was Genadyne Hybrid Foam Dressings approved by the FDA?

Genadyne Hybrid Foam Dressings received FDA 510(k) clearance on 2023-06-12, under approval number K221888.

What company makes Genadyne Hybrid Foam Dressings?

Genadyne Hybrid Foam Dressings is manufactured by Genadyne Biotechnologies, Inc..

What is the FDA product code for Genadyne Hybrid Foam Dressings?

The FDA product code for Genadyne Hybrid Foam Dressings 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 K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) K233614Genadyne DUO NPWT

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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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