# K961356: Mammary Sizer

- Pathway: 510(k) (Traditional)
- Applicant: General Surgical Innovations
- Decided: Sep 23, 1996 after 168 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. The FDA summary names its predicate without a number.
- (no number) Mentor's Volume Sizer for Mammary Implants: named in the summary without a submission number

## Indications for use
The GSI, Inc. Mammary Sizer is intended to assist in evaluation of the appropriate mammary prosthesis volume for each patient prior to implantation.

Source page: https://510kreport.com/device/K961356
Methodology: https://510kreport.com/methodology