K152496 is an FDA 510(k) clearance for the CPX 4 Breast Tissue Expander. This device is classified as a Tissue Expander And Accessories.
Submitted by Mentor Worldwide, LLC (Santa Barbara, US). The FDA issued a Cleared decision on February 19, 2016, 171 days after receiving the submission on September 1, 2015.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K152496 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 2015 |
| Decision Date | February 19, 2016 |
| Days to Decision | 171 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LCJ — Tissue Expander And Accessories |
| Device Class | — |