# K904265: Inamed Ruiz-Cohen Intraoperative Tissue Expander

- Pathway: 510(k) (Traditional)
- Applicant: Inamed Development Co.
- Decided: Mar 6, 1991 after 169 days
- Product code: FZW (Expander, Surgical, Skin Graft)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K972109: Spacemaker Surgicalballoon Dissector/Expander (1997), 1 descendant of its own
- K080158: LB Medical Inflatable Tissue Elevator/Expander System (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K904265
Methodology: https://510kreport.com/methodology