K254126 is an FDA 510(k) clearance for the Natrelle 133S Tissue Expanders. This device is classified as a Tissue Expander And Accessories.
Submitted by AbbVie (Irvine, US). The FDA issued a Cleared decision on January 16, 2026, 28 days after receiving the submission on December 19, 2025.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K254126 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2025 |
| Decision Date | January 16, 2026 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LCJ — Tissue Expander And Accessories |
| Device Class | — |