K243271
- 510(k) number
- K243271
- Device name
- MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Enhance Single Use Gel Sizer
- Applicant
- Mentor Worldwide, LLC CA · US
- Product code
- MRD — Mammary Sizer
- Decision date
- 2025-01-13
- Date received
- 2024-10-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K243271.pdf
Official FDA record: K243271
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.