General Surgical Innovations - FDA 510(k) Cleared Devices
Recent clearances: SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK, SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER, GSI CANNULA WITH INTRODUCER
14
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - General Surgical Innovations General & Plastic Surgery ✕
13 devices
Cleared
Mar 01, 1999
FIXATION SYSTEM
General & Plastic Surgery
161d
Cleared
Jan 16, 1998
SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON...
General & Plastic Surgery
154d
Cleared
Nov 14, 1997
SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER
General & Plastic Surgery
162d
Cleared
Feb 19, 1997
SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH...
General & Plastic Surgery
222d
Cleared
Sep 23, 1996
MAMMARY SIZER
General & Plastic Surgery
168d
Cleared
Aug 07, 1995
THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA
General & Plastic Surgery
84d
Cleared
Jun 29, 1995
SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULA
General & Plastic Surgery
84d
Cleared
Nov 01, 1994
THE SPACEMAKER AND THE SPACEMAKER II
General & Plastic Surgery
54d
Cleared
Oct 05, 1994
GSI KNOTMAKER
General & Plastic Surgery
20d
Cleared
Aug 09, 1994
GSI CANNULA REDUCER ACCESSORY
General & Plastic Surgery
14d
Cleared
Jul 07, 1994
SPECIMEN REMOVAL DEVICE
General & Plastic Surgery
114d
Cleared
Feb 22, 1994
SURGICAL PATCH SPREADER
General & Plastic Surgery
337d
Cleared
Jun 25, 1993
SURGICAL DISSECTOR WITH CANNULA
General & Plastic Surgery
210d