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FDA 510(k)

Avance Foam Dressing Kit - XL

K-Number: K161935 · 2016-11-04

ApplicantMolnlycke Health Care Us, LLC
Decision Date2016-11-04
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Avance Foam Dressing Kit - XL is a medical device manufactured by Molnlycke Health Care Us, LLC. It received FDA 510(k) clearance on 2016-11-04 under approval number K161935. 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 Avance Foam Dressing Kit - XL?

Avance Foam Dressing Kit - XL is a medical device that received FDA 510(k) clearance on 2016-11-04. It is manufactured by Molnlycke Health Care Us, LLC. The 510(k) number is K161935.

When was Avance Foam Dressing Kit - XL approved by the FDA?

Avance Foam Dressing Kit - XL received FDA 510(k) clearance on 2016-11-04, under approval number K161935.

What company makes Avance Foam Dressing Kit - XL?

Avance Foam Dressing Kit - XL is manufactured by Molnlycke Health Care Us, LLC.

What is the FDA product code for Avance Foam Dressing Kit - XL?

The FDA product code for Avance Foam Dressing Kit - XL is OMP.

Other Devices by Molnlycke Health Care Us, LLC

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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 K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC K161410VT·One, VT·One 60daysCarilex Medical, Inc.

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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