K242963 is an FDA 510(k) clearance for the MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs. This device is classified as 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 FDA review panel.
| 510(k) Number | K242963 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 | - |