# K962702: Spacemaker Serial Surgical Balloon Dissector, with Cannula, with Visualization and with Visualization and Cannula

- Pathway: 510(k) (Traditional)
- Applicant: General Surgical Innovations
- Decided: Feb 19, 1997 after 222 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
Longest line of descent: 1 generation back to K944418 (1994). 2 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944418: The Spacemaker and the Spacemaker II, General Surgical Innovations (1994) Summary page 1.
- K951878: Spacemaker, II Surgical Balloon Dissector with and Without a Cannula, General Surgical Innovations (1995) Summary page 1.

## Most influential descendants
- 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
- K110820: Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System (2011), 5 descendants of its own

## Indications for use
The intended use of the Spacemaker® Serial Surgical Balloon Dissector and the predicate devices is to dissect layers of connective tissue along natural planes of separation. The cannula portion of the device is intended to provide access for operative and diagnostic instruments for the duration of the operative procedure.

Source page: https://510kreport.com/device/K962702
Methodology: https://510kreport.com/methodology