FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)
K Number: K170075
·
Decision Apr 3, 2017
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
3
Review Days
84
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Basic Information
- Device Name
- AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)
- K Number
- K170075
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3510
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Airxpanders, Inc.
- Date Received
- January 9, 2017
- Decision Date
- April 3, 2017
- Product Code
- PQN
- 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 |
|---|---|---|---|
| PQN | Carbon Dioxide Gas Controlled Tissue Expander | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PQN), ordered by most recent decision date.
AeroForm Tissue Expander, Smooth
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AeroForm Tissue Expander System
FDA 510(k)
FDA Class 2
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