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General Surgical Innovations

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K983318 FIXATION SYSTEMGDW1999-03-01 View
510(k) K973046 SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAKGCJ1998-01-16 View
510(k) K972109 SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDERFZW1997-11-14 View
510(k) K970201 GSI CANNULA WITH INTRODUCERDYB1997-04-21 View
510(k) K962702 SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULAGCJ1997-02-19 View
510(k) K961356 MAMMARY SIZERMRD1996-09-23 View
510(k) K952278 THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULAGCJ1995-08-07 View
510(k) K951878 SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULAGCJ1995-06-29 View
510(k) K944418 THE SPACEMAKER AND THE SPACEMAKER IIGCJ1994-11-01 View
510(k) K944536 GSI KNOTMAKERGCJ1994-10-05 View
510(k) K943671 GSI CANNULA REDUCER ACCESSORYGCJ1994-08-09 View
510(k) K941249 SPECIMEN REMOVAL DEVICEGCJ1994-07-07 View
510(k) K931425 SURGICAL PATCH SPREADERGCJ1994-02-22 View
510(k) K926010 SURGICAL DISSECTOR WITH CANNULAGCJ1993-06-25 View
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