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FDA 510(k)

ACTIV.A.C. Negative Pressure Wound Therapy System

K-Number: K201571 · 2020-07-08

ApplicantKci USA, Inc.
Decision Date2020-07-08
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACTIV.A.C. Negative Pressure Wound Therapy System is a medical device manufactured by Kci USA, Inc.. It received FDA 510(k) clearance on 2020-07-08 under approval number K201571. 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 ACTIV.A.C. Negative Pressure Wound Therapy System?

ACTIV.A.C. Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2020-07-08. It is manufactured by Kci USA, Inc.. The 510(k) number is K201571.

When was ACTIV.A.C. Negative Pressure Wound Therapy System approved by the FDA?

ACTIV.A.C. Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2020-07-08, under approval number K201571.

What company makes ACTIV.A.C. Negative Pressure Wound Therapy System?

ACTIV.A.C. Negative Pressure Wound Therapy System is manufactured by Kci USA, Inc..

What is the FDA product code for ACTIV.A.C. Negative Pressure Wound Therapy System?

The FDA product code for ACTIV.A.C. Negative Pressure Wound Therapy System is OMP.

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Related PubMed Literature

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Other Devices by Kci USA, Inc.

K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System K153199Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack K180855Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System K173447V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit K190697PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)

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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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