# K984106: Mammary Sizer, Mammary Prothesis Sizer

- Pathway: 510(k) (Traditional)
- Applicant: Specialty Surgical Products, Inc.
- Decided: Feb 12, 1999 after 87 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The mammary sizer is designed for single use, temporary intraoperative placement in a surgically prepared mammary pocket. The sizer is used to evaluate the appropriate mammary prosthesis volume for each patient prior to implantation of a mammary prosthesis.

Source page: https://510kreport.com/device/K984106
Methodology: https://510kreport.com/methodology