K241918 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 August 2, 2024, 32 days after receiving the submission on July 1, 2024.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K241918 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2024 |
| Decision Date | August 02, 2024 |
| Days to Decision | 32 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LCJ — Tissue Expander And Accessories |
| Device Class | — |