K242963 is an FDA 510(k) clearance for the MENTOR? PliaForm? Breast Tissue Expander w/ Suture Tabs, a Tissue Expander And Accessories, submitted by Mentor Worldwide, LLC (Irvine, US). The FDA issued a Cleared decision on April 24, 2025, 211 days after receiving the submission on September 25, 2024. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K242963 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 25, 2024 |
| Decision Date | April 24, 2025 |
| Days to Decision | 211 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LCJ — Tissue Expander And Accessories |
| Device Class | — |