# K161483: Unger Quad Injector

- Pathway: 510(k) (Traditional)
- Applicant: Stradis Healthcare
- Decided: Oct 31, 2016 after 153 days
- Product code: LCJ (Tissue Expander And Accessories)
- 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: 1 generation back to K870754 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870754: Mcghan Tissue Expander Fill System, Mcghan Medical Corp. (1987) Summary page 5.

## Indications for use
The Unger Quad Injector is intended to be used as the needle infusion set component of a tissue expander fill kit for breast tissue expanders designed to be filled with sterile saline using 21-gauge needles. Specifically, the Unger Quad Injector is indicated for assisting the clinician in delivery of sterile saline into the surgically-placed, sub-dermal, temporary, removable tissue expander.

Source page: https://510kreport.com/device/K161483
Methodology: https://510kreport.com/methodology