510(k) K242963
K242963 is an FDA 510(k) premarket notification submitted by Mentor Worldwide, LLC for the device "MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs". The FDA issued a decision of Substantially Equivalent on April 24, 2025. The device falls under product code LCJ (Tissue Expander And Accessories), a Class U device. Mentor Worldwide, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 24, 2025
- Date Received
- September 25, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tissue Expander And Accessories
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type