K243836
- 510(k) number
- K243836
- Device name
- Mentor CPX 4 PLUS Enhance Breast Tissue Expander
- Applicant
- Mentor Worldwide, LLC CA · US
- Product code
- LCJ — Tissue Expander And Accessories
- Decision date
- 2025-01-12
- Date received
- 2024-12-13
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K243836.pdf
Official FDA record: K243836
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.