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FDA 510(k)

Invia® Integrated Dressing

K-Number: K223388 · 2023-07-07

ApplicantMedela AG
Decision Date2023-07-07
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Invia® Integrated Dressing is a medical device manufactured by Medela AG. It received FDA 510(k) clearance on 2023-07-07 under approval number K223388. 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 Invia® Integrated Dressing?

Invia® Integrated Dressing is a medical device that received FDA 510(k) clearance on 2023-07-07. It is manufactured by Medela AG. The 510(k) number is K223388.

When was Invia® Integrated Dressing approved by the FDA?

Invia® Integrated Dressing received FDA 510(k) clearance on 2023-07-07, under approval number K223388.

What company makes Invia® Integrated Dressing?

Invia® Integrated Dressing is manufactured by Medela AG.

What is the FDA product code for Invia® Integrated Dressing?

The FDA product code for Invia® Integrated Dressing is OMP.

Other Devices by Medela AG

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 Supply K153663Vario 8/18/ci K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film K180415Invia White Foam NPWT K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad K191653Freestyle Flex

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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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