K254126
- 510(k) number
- K254126
- Device name
- Natrelle 133S Tissue Expanders
- Applicant
- AbbVie CA · US
- Product code
- LCJ — Tissue Expander And Accessories
- Decision date
- 2026-01-16
- Date received
- 2025-12-19
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K254126.pdf
Official FDA record: K254126
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.