SICAT GMBH & CO. KG

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
9
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2951-2020Class IISICAT IMPLANT V2.0July 15, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K192348SICAT Implant V2.0December 4, 2019
K180262SICAT EndoMarch 12, 2018
K153291SICAT OPTISLEEPMarch 31, 2016
K143655SICAT OPTIMOTIONOctober 2, 2015
K133320SICAT FUNCTIONFebruary 25, 2014
K103723SICAT IMPLANT V1.2May 20, 2011
K093090GALILEOS IMPLANT, VERSION 1.7December 17, 2009
K090119SICAT IMPLANTFebruary 5, 2009
K061472GALILEOS IMPLANT, V 1.0June 9, 2006