# FZW: Expander, Surgical, Skin Graft

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 8
- Recalls: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1987: 1
- 1988: 1
- 1990: 1
- 1991: 1
- 1994: 1
- 1997: 1
- 1999: 1
- 2008: 1

## Most-cited predicates
- K904265: Inamed Ruiz-Cohen Intraoperative Tissue Expander (1991), cited by 1
- K874276: Cui, Versafil (TM), Ste (TM) Tissue Expander (1987), cited by 1
- K972109: Spacemaker Surgicalballoon Dissector/Expander (1997), cited by 1

Source page: https://510kreport.com/product-code/FZW
Data by year (CSV): https://510kreport.com/product-code/FZW.csv