K214124 is an FDA 510(k) clearance for the AlloX2 Pro Tissue Expanders. This device is classified as a Tissue Expander And Accessories.
Submitted by Sientra, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on June 8, 2023, 525 days after receiving the submission on December 30, 2021.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K214124 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2021 |
| Decision Date | June 08, 2023 |
| Days to Decision | 525 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LCJ - Tissue Expander And Accessories |
| Device Class | - |