K242963
- 510(k) number
- K242963
- Device name
- MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs
- Applicant
- Mentor Worldwide, LLC CA · US
- Product code
- LCJ — Tissue Expander And Accessories
- Decision date
- 2025-04-24
- Date received
- 2024-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242963.pdf
Official FDA record: K242963
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.