FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXTRICARE NPWT FOOT DRESSING
K Number: K131464
·
Decision Aug 13, 2013
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
204
Applicant Total
10
Review Days
84
Basic Information
- Device Name
- EXTRICARE NPWT FOOT DRESSING
- K Number
- K131464
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- DEVON MEDICAL INC.
- Date Received
- May 21, 2013
- Decision Date
- August 13, 2013
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OMP), ordered by most recent decision date.
Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Genadyne DUO NPWT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VERSA Negative Pressure Wound Therapy System (VCMPP-100)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Negative Pressure Wound Therapy Device (V-Move, V-Grand)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEXA NPWT System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by DEVON MEDICAL INC.
| K Number | Device Name | ||
|---|---|---|---|
| K132225 | EXTRICARE | May 15, 2014 | Substantially Equivalent |
| K131743 | CIRONA DVT FOOT GARMENT | Jul 1, 2013 | Substantially Equivalent |
| K130571 | DEVON CIRONA 6100 DVT | Apr 9, 2013 | Substantially Equivalent |
| K123959 | CIRCUFLOW 5150 | Feb 28, 2013 | Substantially Equivalent |
| K123647 | CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE | Feb 14, 2013 | Substantially Equivalent |
| K102582 | ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE | Oct 7, 2010 | Substantially Equivalent |
| K101523 | CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE | Jun 17, 2010 | Substantially Equivalent |
| K100446 | CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE | Mar 5, 2010 | Substantially Equivalent |
| K090664 | DEVON ACCUBP CUFF | Mar 23, 2009 | Substantially Equivalent |