K170075 is an FDA 510(k) clearance for the AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5). 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 Cleared decision on April 3, 2017, 84 days after receiving the submission on January 9, 2017.
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 | K170075 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 2017 |
| Decision Date | April 03, 2017 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| 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. |