# K973046: Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon Dissector, Saphtrak

- Pathway: 510(k) (Traditional)
- Applicant: General Surgical Innovations
- Decided: Jan 16, 1998 after 154 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: 2 generations back to K944418 (1994). 10 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926010: Surgical Dissector with Cannula, General Surgical Innovations (1993) Summary page 1.
- 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.
- K952278: The Reusable Spacemaker Surgical Balloon Dissector & Cannula, General Surgical Innovations (1995) Summary page 1.
- K962702: Spacemaker Serial Surgical Balloon Dissector, with Cannula, with Visualization and with Visualization and Cannula, General Surgical Innovations (1997) Summary page 1.
- K953377: Distention Balloon, Origin Medsystems, Inc. (1995) Summary page 1.
- K935426: Preperitoneal Distention Balloon System, Origin Medsystems, Inc. (1994) Summary page 1.
- K946002: Origin Preperitoneal Dissection Balloon System (PDBS)--Extra, Origin Medsystems, Inc. (1995) Summary page 1.
- K954174: Duo Balloon System (DBS) 2 [10 and 12 MM Sizes], Origin Medsystems, Inc. (1995) Summary page 1.
- K964171: Vasoview Balloon Dissection System, Origin Medsystems, Inc. (1997) Summary page 1.

## Most influential descendants
- 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
- K122436: Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS Positioning System (2012), 4 descendants of its own

## Indications for use
The device is indicated for any area of the body where it is necessary to separate the layers of connective tissue for surgical access. The intended use of the Spacemaker® Surgical Balloon Dissectors is to create a operative space by dissecting layers of connective tissue along natural tissue planes of separation of the extraperitoneal (including preperitoneal and retroperitoneal), or subcutaneous extremity or thoracic space. The indications for use include dissection of tissue for the following surgical procedures: endoscopic; laparoscopic; general surgery; plastic and reconstructive surgery, including aesthetic surgery; vascular surgery for the exposure of superficial vessels of the upper and/or lower extremities (no deep structure would be targeted), including the saphenous vein and femoral vessels; thoracoscopic procedures involving exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall, procedures in the extraperitoneal space involving dissection of tissue layers allowing exposure of structures including: adrenals, bone, spine, lymph nodes, and kidneys. Examples of specific surgical procedures the Spacemaker® Surgical Balloon Dissectors may be used to facilitate tissue dissection include: fascial layers between the skin and peritoneum, hernia repair, varicocele dissection, sympathectomy, lymph node dissection, urethropexy, subfascial perforator vein ligation, access to the saphenous vein and femoral vessels, retroperitoneal access to the anterior spine, access for long bone plating. The cannula portion of the device is intended to provide access for surgical and diagnostic instruments for the duration of the operative procedure.

Source page: https://510kreport.com/device/K973046
Methodology: https://510kreport.com/methodology