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Crospon, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K183072EndoFLIP SystemFebruary 15, 2019
K172128EsoFLIP® ES-310 Balloon CatheterNovember 22, 2017
K170833EndoFLIP® System with FLIP Topography moduleApril 17, 2017
K160725EndoFLIPMay 1, 2016
K142000ESOFLIP ESSeptember 25, 2014
K132337ESOFLIP BALLOON DILATION CATHETEROctober 7, 2013
K130906ENDOFLIP CATHETERJuly 17, 2013
K120997BAROSTAT SOFTWARE OPTIONAugust 27, 2012
K110531ENDOFLIP ECDOctober 6, 2011
K110529ENDOFLIP GASTRIC TUBEJuly 22, 2011
K102214ENDO FLIPDecember 16, 2010
K092850ENDOFLIPDecember 15, 2009