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FDA 510(k)

Invia White Foam NPWT

K-Number: K180415 · 2018-11-02

ApplicantMedela AG
Decision Date2018-11-02
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Invia White Foam NPWT is a medical device manufactured by Medela AG. It received FDA 510(k) clearance on 2018-11-02 under approval number K180415. 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 White Foam NPWT?

Invia White Foam NPWT is a medical device that received FDA 510(k) clearance on 2018-11-02. It is manufactured by Medela AG. The 510(k) number is K180415.

When was Invia White Foam NPWT approved by the FDA?

Invia White Foam NPWT received FDA 510(k) clearance on 2018-11-02, under approval number K180415.

What company makes Invia White Foam NPWT?

Invia White Foam NPWT is manufactured by Medela AG.

What is the FDA product code for Invia White Foam NPWT?

The FDA product code for Invia White Foam NPWT 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 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 K182191Invia Abdominal Dressing Kit

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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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