510(k) K243836
K243836 is an FDA 510(k) premarket notification submitted by Mentor Worldwide, LLC for the device "Mentor CPX 4 PLUS Enhance Breast Tissue Expander". The FDA issued a decision of Substantially Equivalent on January 12, 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
- January 12, 2025
- Date Received
- December 13, 2024
- Clearance Type
- Special
- 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