K191138 is an FDA 510(k) clearance for the AeroForm Tissue Expander, Smooth. This device is classified as a Carbon Dioxide Gas Controlled Tissue Expander (Class II - Special Controls, product code PQN).
Submitted by Airxpanders, Inc. (San Jose, US). The FDA issued a Cleared decision on July 11, 2019, 72 days after receiving the submission on April 30, 2019.
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 | K191138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2019 |
| Decision Date | July 11, 2019 |
| Days to Decision | 72 days |
| Submission Type | Special |
| 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. |