# K951878: Spacemaker, II Surgical Balloon Dissector with and Without a Cannula

- Pathway: 510(k) (Traditional)
- Applicant: General Surgical Innovations
- Decided: Jun 29, 1995 after 84 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K962702: Spacemaker Serial Surgical Balloon Dissector, with Cannula, with Visualization and with Visualization and Cannula (1997), 11 descendants of its own
- K973046: Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon Dissector, Saphtrak (1998), 10 descendants of its own
- K090631: Pajunk Disposable Balloons and Balloon Systems (2009), 9 descendants of its own
- K092726: Mesh GPS - Large, Small, SM, SM Small (2010), 7 descendants of its own
- K102766: Composix L/P Mesh with Echo PS Positioning System (2010), 6 descendants of its own

Source page: https://510kreport.com/device/K951878
Methodology: https://510kreport.com/methodology