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IntroMedic Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
10
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1615-2018Class IIMiriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System isFebruary 15, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K180732MiroCam Capsule Endoscope SystemNovember 8, 2018
K170438MiroCam Capsule Endoscope SystemJanuary 30, 2018
K143663MiroCam Capsule Endoscope SystemMarch 17, 2015
K134005MIROCAM CAPSULE ENDOSCOPE SYSTEMJuly 9, 2014
K140751MIROCAM CAPSULE ENDOSCOPE SYSTEMJune 30, 2014
K131131E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEMJune 21, 2013
K123428MIROCAM CAPSULE ENDOSCOPE SYSTEMMay 20, 2013
K120702E.G. SCAN II ESPHAGOSCOPE SYSTEMJune 20, 2012
K111450MIROCAM CAPSULE ENDOSCOPE SYSTEMMay 18, 2012
K111030E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEMOctober 21, 2011