# General Surgical Innovations

- Location (FDA's records): Palo Alto, CA
- FDA decisions: 14 (1993–1999): 14 510(k) clearances
- Product codes: GCJ (10), DYB (1), MRD (1), GDW (1), FZW (1)
- Predicates its devices cite: 17 (8 its own); citations of its devices by later devices: 11 (8 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Origin Medsystems, Inc.: 5 (https://510kreport.com/company/origin-medsystems)
- Mcghan Medical Corp.: 2 (https://510kreport.com/company/mcghan-medical)
- Marlo Surgical Technology: 1 (https://510kreport.com/company/marlo-surgical-technology)
- Inamed Development Co.: 1 (https://510kreport.com/company/inamed-development)

## Firms that cite its devices most
- Lb Medical LLC: 1 (https://510kreport.com/company/lb-medical)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)
- PAJUNK GmbH Medizintechnologie: 1 (https://510kreport.com/company/pajunk-medizintechnologie)

## Its most-cited devices
- K951878: Spacemaker, II Surgical Balloon Dissector with and Without a Cannula (1995), cited by 3
- K973046: Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon Dissector, Saphtrak (1998), cited by 2
- K944418: The Spacemaker and the Spacemaker II (1994), cited by 2
- K952278: The Reusable Spacemaker Surgical Balloon Dissector & Cannula (1995), cited by 1
- K962702: Spacemaker Serial Surgical Balloon Dissector, with Cannula, with Visualization and with Visualization and Cannula (1997), cited by 1
- K972109: Spacemaker Surgicalballoon Dissector/Expander (1997), cited by 1

## Recent decisions
- K983318: Fixation System (Mar 1, 1999)
- K973046: Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon Dissector, Saphtrak (Jan 16, 1998)
- K972109: Spacemaker Surgicalballoon Dissector/Expander (Nov 14, 1997)
- K970201: Gsi Cannula with Introducer (Apr 21, 1997)
- K962702: Spacemaker Serial Surgical Balloon Dissector, with Cannula, with Visualization and with Visualization and Cannula (Feb 19, 1997)
- K961356: Mammary Sizer (Sep 23, 1996)
- K952278: The Reusable Spacemaker Surgical Balloon Dissector & Cannula (Aug 7, 1995)
- K951878: Spacemaker, II Surgical Balloon Dissector with and Without a Cannula (Jun 29, 1995)

Source page: https://510kreport.com/company/general-surgical-innovations