Kci USA, Inc. - FDA 510(k) Cleared Devices

Cleared May 23, 2024

3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)

K241134 · OMP

General & Plastic Surgery · 29d

Cleared Jul 08, 2020

ACTIV.A.C. Negative Pressure Wound Therapy System

K201571 · OMP

General & Plastic Surgery · 27d

Cleared May 18, 2020

V.A.C. DERMATAC Drape

K200390 · OMP

General & Plastic Surgery · 90d

Cleared Nov 22, 2019

PREVENA PLUS Incision Management System (No Ag)

K190697 · OMP

General & Plastic Surgery · 249d

Not Cleared Apr 19, 2019

PREVENA 125 and PREVENA PLUS 125 Therapy Units

DEN180013 · QFC

General & Plastic Surgery · 400d

Cleared Mar 28, 2019

V.A.C. DERMATAC Drape

K181505 · OMP

General & Plastic Surgery · 294d

Cleared Mar 20, 2019

ACTIV.A.C. Therapy Unit

K183543 · OMP

General & Plastic Surgery · 90d

Cleared Feb 15, 2019

PREVENA RESTOR(TM) Incision Management System

K181507 · OMP

General & Plastic Surgery · 253d

Cleared Jun 01, 2018

Prevena Plus Incision Management System, Prevena Plus Duo Incision Management...

K180855 · OMP

General & Plastic Surgery · 60d

Cleared Mar 09, 2018

PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management...

K173426 · OMP

General & Plastic Surgery · 127d

Cleared Mar 02, 2018

V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA...

K173447 · OMP

General & Plastic Surgery · 116d

Cleared Dec 09, 2016

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

K160487 · OMP

General & Plastic Surgery · 291d