DEN150055 is an FDA 510(k) submission for the AeroForm Tissue Expander System. This device is classified as a Carbon Dioxide Gas Controlled Tissue Expander (Class II - Special Controls, product code PQN).
Submitted by Airxpanders, Inc. (Palo Alto, US). The FDA issued a Not Cleared (DENG) decision on December 21, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3510. A Carbon Dioxide Gas Controlled Tissue Expander Is Intended For Tissue Expansion..
| 510(k) Number | DEN150055 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 07, 2015 |
| Decision Date | December 21, 2016 |
| Days to Decision | 380 days |
| Submission Type | Direct |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | PQN - Carbon Dioxide Gas Controlled Tissue Expander |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3510 |
| Definition | A Carbon Dioxide Gas Controlled Tissue Expander Is Intended For Tissue Expansion. |