510(k) DEN180013

PREVENA 125 and PREVENA PLUS 125 Therapy Units by Kci USA, Inc. — Product Code QFC

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: April 19, 2019
Date Received: March 15, 2018
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
Device Class: Class II
Regulation Number: 878.4783
Review Panel: SU
Submission Type

A negative pressure wound therapy device for reduction of wound complications is a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. This device type is intended for use with wound dressings classified under 21 CFR 878.4780. This classification does not include devices intended for organ space wounds.

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K200390 — V.A.C. DERMATAC Drape (May 18, 2020)
K190697 — PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Manag (November 22, 2019)
K181505 — V.A.C. DERMATAC Drape (March 28, 2019)
K183543 — ACTIV.A.C. Therapy Unit (March 20, 2019)
K181507 — PREVENA RESTOR(TM) Incision Management System (February 15, 2019)
K180855 — Prevena Plus Incision Management System, Prevena Plus Duo Incision Management Sy (June 1, 2018)
K173426 — PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management Sy (March 9, 2018)
K173447 — V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Neg (March 2, 2018)

510(k) DEN180013

Clearance Details

Device Classification

Other clearances by Kci USA, Inc.

Other clearances for product code QFC