FDA 510(k)

V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System

K-Number: K160487 · 2016-12-09

Decision Date2016-12-09

Product CodeOMP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System is a medical device manufactured by Kci USA, Inc.. It received FDA 510(k) clearance on 2016-12-09 under approval number K160487. 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 V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System?

V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System is a medical device that received FDA 510(k) clearance on 2016-12-09. It is manufactured by Kci USA, Inc.. The 510(k) number is K160487.

When was V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System approved by the FDA?

V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System received FDA 510(k) clearance on 2016-12-09, under approval number K160487.

What company makes V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System?

V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System is manufactured by Kci USA, Inc..

What is the FDA product code for V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System?

The FDA product code for V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System is OMP.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.