FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K Number: K113678
·
Decision Oct 1, 2012
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
204
Applicant Total
19
Review Days
292
Basic Information
- Device Name
- INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM
- K Number
- K113678
- 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
- MEDELA AG
- Date Received
- December 14, 2011
- Decision Date
- October 1, 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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|---|---|---|---|
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| K150499 | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty | Apr 21, 2015 | Substantially Equivalent |
| K150134 | Basic, Dominant Flex, KV-6 | Apr 21, 2015 | Substantially Equivalent |
| K141926 | INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM | Dec 19, 2014 | Substantially Equivalent |
| K141553 | MEDELA THOPAZ+ | Aug 25, 2014 | Substantially Equivalent |
| K130123 | BASIC AND DOMINANT FLEX SUCTION PUMPS | Oct 11, 2013 | Substantially Equivalent |
| K130210 | MEDELA THOPAZ | Mar 15, 2013 | Substantially Equivalent |
| K080357 | MEDELA INVIA WOUND THERAPY | Jul 24, 2008 | Substantially Equivalent |
| K080212 | MEDELA THOPAZ, MODEL 200 0288 | Jul 23, 2008 | Substantially Equivalent |