FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT
K Number: K120033
·
Decision May 31, 2012
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
204
Applicant Total
17
Review Days
148
Basic Information
- Device Name
- ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT
- K Number
- K120033
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- KCI USA, INC.
- Date Received
- January 4, 2012
- Decision Date
- May 31, 2012
- Product Code
- OMP
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | FDA class 2 | General, Plastic Surgery |
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Other Clearances by KCI USA, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K173426 | PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System | Mar 9, 2018 | Substantially Equivalent |
| K153199 | Prevena 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 | Feb 29, 2016 | Substantially Equivalent |
| K150006 | Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing | Nov 6, 2015 | Substantially Equivalent |
| K133276 | V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS | Nov 19, 2013 | Substantially Equivalent |
| K132741 | V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM | Nov 15, 2013 | Substantially Equivalent |
| K123507 | KCI NPWT GAUZE DRESSING | Apr 4, 2013 | Substantially Equivalent |
| K111280 | V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT | Jul 21, 2011 | Substantially Equivalent |
| K100821 | PREVENA INCISION MANAGEMENT SYSTEM | Jun 11, 2010 | Substantially Equivalent |
| K091585 | VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100 | Dec 29, 2009 | Substantially Equivalent |
| K090489 | ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026 | May 14, 2009 | Substantially Equivalent |