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General Surgical Innovations

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K983318FIXATION SYSTEMMarch 1, 1999
K973046SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAKJanuary 16, 1998
K972109SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDERNovember 14, 1997
K970201GSI CANNULA WITH INTRODUCERApril 21, 1997
K962702SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATIOFebruary 19, 1997
K961356MAMMARY SIZERSeptember 23, 1996
K952278THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULAAugust 7, 1995
K951878SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULAJune 29, 1995
K944418THE SPACEMAKER AND THE SPACEMAKER IINovember 1, 1994
K944536GSI KNOTMAKEROctober 5, 1994
K943671GSI CANNULA REDUCER ACCESSORYAugust 9, 1994
K941249SPECIMEN REMOVAL DEVICEJuly 7, 1994
K931425SURGICAL PATCH SPREADERFebruary 22, 1994
K926010SURGICAL DISSECTOR WITH CANNULAJune 25, 1993