OMP · Class II · 21 CFR 878.4780

FDA Product Code OMP: Negative Pressure Wound Therapy Powered Suction Pump

FDA product code OMP covers powered suction pumps for negative pressure wound therapy.

These devices apply controlled sub-atmospheric pressure to a wound bed via a foam or gauze dressing and sealed film, promoting granulation tissue formation, reducing edema, and removing wound exudate. NPWT is used in the management of complex wounds, surgical incisions, and pressure injuries.

OMP devices are Class II medical devices, regulated under 21 CFR 878.4780 and reviewed by the FDA General & Plastic Surgery panel.

Leading manufacturers include Smith & Nephew, Inc., Smith & Nephew Medical Limited and Kci USA, Inc..

212
Total
212
Cleared
191d
Avg days
1997
Since
212 devices
73–96 of 212
Cleared Jun 01, 2018
Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System
K180855
Kci USA, Inc.
General & Plastic Surgery · 60d
Cleared May 09, 2018
Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad
K172145
Medela AG
General & Plastic Surgery · 296d
Cleared Apr 20, 2018
PICO Single Use Negative Pressure Wound Therapy System
K180618
Smith & Nephew Medical Limited
General & Plastic Surgery · 42d
Cleared Apr 06, 2018
PICO Single Use Negative Pressure Wound Therapy System
K180614
Smith & Nephew Medical Limited
General & Plastic Surgery · 29d
Cleared Mar 09, 2018
PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System
K173426
Kci USA, Inc.
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 Negative Pressure Wound Therapy Unit
K173447
Kci USA, Inc.
General & Plastic Surgery · 116d
Cleared Feb 02, 2018
PICO 7 Single Use Negative Pressure Wound Therapy System
K172005
Smith & Nephew Medical Limited
General & Plastic Surgery · 214d
Cleared Sep 29, 2016
RENASYS GO
K152163
Smith & Nephew, Inc.
General & Plastic Surgery · 423d
Cleared Aug 31, 2016
RENASYS-G Gauze Dressing Kits with Soft Port
K162129
Smith & Nephew, Inc.
General & Plastic Surgery · 30d
Cleared Jul 23, 2015
RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device
K143133
Smith & Nephew, Inc.
General & Plastic Surgery · 265d
Cleared Jul 16, 2015
RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device
K151326
Smith & Nephew, Inc.
General & Plastic Surgery · 59d
Cleared Apr 29, 2015
RENASYS
K142979
Smith & Nephew, Inc.
General & Plastic Surgery · 196d
Cleared Oct 23, 2013
RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE
K132446
Smith & Nephew, Inc.
General & Plastic Surgery · 78d
Cleared May 16, 2012
PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K112127
Smith & Nephew, Inc.
General & Plastic Surgery · 296d
Cleared Dec 15, 2011
PICO
K111170
Smith & Nephew, Inc.
General & Plastic Surgery · 233d
Cleared Jun 22, 2011
RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD
K110647
Smith & Nephew, Inc.
General & Plastic Surgery · 107d
Cleared Aug 06, 2010
MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY
K102001
Smith & Nephew, Inc.
General & Plastic Surgery · 22d
Cleared Jul 09, 2009
RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059
K091470
Smith & Nephew, Inc.
General & Plastic Surgery · 52d
Cleared Feb 25, 2009
RENASYS GO NEGATIVE PRESSURE WOUND THERAPY
K083375
Smith & Nephew, Inc.
General & Plastic Surgery · 103d
Cleared Nov 14, 2008
RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS
K082211
Smith & Nephew, Inc.
General & Plastic Surgery · 100d
Cleared Sep 05, 2008
RENASYS EZ
K082426
Smith & Nephew, Inc.
General & Plastic Surgery · 14d