# K241552: MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer

- Pathway: 510(k) (Traditional)
- Applicant: Mentor Worldwide, LLC
- Decided: Sep 6, 2024 after 98 days
- Product code: MRD (Mammary Sizer)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010709 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062421: Mentor Resterilizable Gel Breast Implant Sizer, Mentor Corporation (2006) Summary page 5.

## Most influential descendants
- K243271: MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (2025), 0 descendants of its own

## Indications for use
The MENTOR MemoryGel™ Enhance Single Use Gel Breast Implant Sizer is indicated for single use only for temporary insertion intraoperatively to evaluate the shape and size of the MemoryGel™ Enhance Breast Implant to be implanted.

Source page: https://510kreport.com/device/K241552
Methodology: https://510kreport.com/methodology