# K972109: Spacemaker Surgicalballoon Dissector/Expander

- Pathway: 510(k) (Traditional)
- Applicant: General Surgical Innovations
- Decided: Nov 14, 1997 after 162 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
Longest line of descent: 1 generation back to K843704 (1984). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951878: Spacemaker, II Surgical Balloon Dissector with and Without a Cannula, General Surgical Innovations (1995) Summary page 5.
- K904265: Inamed Ruiz-Cohen Intraoperative Tissue Expander, Inamed Development Co. (1991) Summary page 5.
- K862203: Mcghan Magna-Site (TM) Tissue Expander, Mcghan Medical Corp. (1986) Summary page 5.
- K843704: Mcghan Tissue Expander, Mcghan Medical Corp. (1984) Summary page 5.

## Most influential descendants
- K080158: LB Medical Inflatable Tissue Elevator/Expander System (2008), 0 descendants of its own

## Indications for use
The intended use of the Spacemaker® Surgical Balloon Dissector/Expander is to create a surgical space anywhere in the body by dissecting layers of connective tissue along natural planes of separation and provide intraoperative and subsequent tissue expansion. The Spacemaker® Surgical Balloon Dissector/Expander is a temporary subcutaneous or submuscular implant device. The indications for use include the following: breast reconstruction, limb reconstruction, correction of congenital deformities and cosmetic defects, and scar revision.

Source page: https://510kreport.com/device/K972109
Methodology: https://510kreport.com/methodology