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Sopro

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
25
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K223470C50December 14, 2023
K121685SOPROCAREMarch 12, 2013
K103813SOPRO 281March 22, 2011
K092329SOPIX 2July 20, 2010
K092583SOPROLIFEJanuary 13, 2010
K082796SOPRO 184 CAMERAApril 1, 2009
K080122SOPRO 670 ARTHROSCOPIC PUMPJuly 11, 2008
K070783SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATORDecember 13, 2007
K072912SOPRO 225 DUAL HALOGEN LIGHT SOURCENovember 16, 2007
K070102SOPRO 162 CAMERAFebruary 20, 2007
K031593SOPRO 61DSeptember 16, 2003
K020915SOPRO LIGHT SOURCES AND ACCESSORIESJune 14, 2002
K020270SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERAMarch 14, 2002
K013090SOPRO 67D OPERATING ROOM CAMERADecember 13, 2001
K012505SOPRO595 INTRA ORAL CAMERAOctober 5, 2001
K000424S51D DIGITAL ENDOSCOPY CAMERAMarch 31, 2000
K000423S52D DIGITAL VIDEO LAPAROSCOPEMarch 31, 2000
K000422S57D DIGITAL OPERATING ROOM CAMERAMarch 31, 2000
K990948S575 INTRAORAL DOCKING DENTAL CAMERAApril 21, 1999
K983625S555 INTRAORAL DENTAL CAMERAJanuary 11, 1999