FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
MEDELA THOPAZ+
K Number: K141553
·
Decision Aug 25, 2014
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
151
Applicant Total
19
Review Days
75
Basic Information
- Device Name
- MEDELA THOPAZ+
- K Number
- K141553
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDELA AG
- Date Received
- June 11, 2014
- Decision Date
- August 25, 2014
- Product Code
- BTA
- 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 |
|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | FDA class 2 | General, Plastic Surgery |
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| K Number | Device Name | ||
|---|---|---|---|
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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 |
| K130123 | BASIC AND DOMINANT FLEX SUCTION PUMPS | Oct 11, 2013 | Substantially Equivalent |
| K130210 | MEDELA THOPAZ | Mar 15, 2013 | Substantially Equivalent |
| K113678 | INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM | Oct 1, 2012 | Substantially Equivalent |
| K080357 | MEDELA INVIA WOUND THERAPY | Jul 24, 2008 | Substantially Equivalent |
| K080212 | MEDELA THOPAZ, MODEL 200 0288 | Jul 23, 2008 | Substantially Equivalent |