PQN
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Carbon Dioxide Gas Controlled Tissue Expander
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3510
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- FDA definition
- A carbon dioxide gas controlled tissue expander is intended for tissue expansion.
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| Record | Firm | Date |
|---|---|---|
| AeroForm Tissue Expander, Smooth (K191138) | Airxpanders, Inc. | 2019-07-11 |
| AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) (K170075) | Airxpanders, Inc. | 2017-04-03 |
| AeroForm Tissue Expander System (DEN150055) | Airxpanders, Inc. | 2016-12-21 |
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