K142998 is an FDA 510(k) clearance for the CPX Control 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 December 19, 2014, 63 days after receiving the submission on October 17, 2014.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K142998 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 2014 |
| Decision Date | December 19, 2014 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LCJ — Tissue Expander And Accessories |
| Device Class | — |