Medical Device Manufacturer · US , San Antonio , TX

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

13 submissions · 13 cleared · Since 2006

Recent clearances: V.A.C.ULTA Negative Pressure Wound Therapy System, PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings, V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...

13
Total
13
Cleared
0
Denied

Kci USA, Inc. (Kinetic Concepts, Inc.) has 13 FDA 510(k) cleared general & plastic surgery devices. Based in San Antonio, US.

Historical record: 13 cleared submissions from 2006 to 2017.

Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Kci USA, Inc. as regulatory consultant.

FDA 510(k) Regulatory Record - Kci USA, Inc. (Kinetic Concepts, Inc.)

13 devices
1-12 of 13
Cleared Jan 26, 2017
V.A.C.ULTA Negative Pressure Wound Therapy System
K162790 · OMP
General & Plastic Surgery · 114d
Cleared Oct 04, 2016
PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE...
K161897 · OMP
General & Plastic Surgery · 85d
Cleared Jun 20, 2016
V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...
K160451 · OMP
General & Plastic Surgery · 123d
Cleared Aug 20, 2015
PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION...
K141017 · OMP
General & Plastic Surgery · 486d
Cleared Mar 24, 2014
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA...
K133232 · OMP
General & Plastic Surgery · 154d
Cleared Jan 15, 2013
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING
K123878 · OMP
General & Plastic Surgery · 29d
Cleared Oct 11, 2012
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA...
K121883 · OMP
General & Plastic Surgery · 105d
Cleared Oct 05, 2012
ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM
K120499 · OMP
General & Plastic Surgery · 227d
Cleared Mar 14, 2011
V.A.C. VERAFLO CLEANSE DRESSING SYSTEM
K103156 · OMP
General & Plastic Surgery · 139d
Cleared Dec 15, 2010
V.A.C. GRANUFOAM SILVER SMALL DRESSING
K102956 · OMP
General & Plastic Surgery · 72d
Cleared Sep 17, 2010
V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY...
K100657 · OMP
General & Plastic Surgery · 193d
Cleared Mar 10, 2010
V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C....
K093526 · OMP
General & Plastic Surgery · 114d
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