K243836 is an FDA 510(k) clearance for the Mentor? CPX ? 4 PLUS Enhance Breast Tissue Expander. This device is classified as a Tissue Expander And Accessories.
Submitted by Mentor Worldwide, LLC (Irvine, US). The FDA issued a Cleared decision on January 12, 2025, 30 days after receiving the submission on December 13, 2024.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K243836 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2024 |
| Decision Date | January 12, 2025 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LCJ — Tissue Expander And Accessories |
| Device Class | — |