IntroMedic Co., Ltd.
FDA Regulatory Profile
IntroMedic Co., Ltd. has 1 FDA recall, 2 inspections, 11 510(k) clearances and 0 compliance actions on record.
What these totals cover: FDA records filed under the name "IntroMedic Co., Ltd." and its spelling variant "Intromedic Co".
On this page: Recalls (1) · Inspections (2) · Facilities (2) · 510(k) clearances (11)
Latest recall Z-1615-2018 · Class II · Feb 15, 2017Latest inspection Jul 6, 2017 · VAI
Latest 510(k) May 8, 2026
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Summary
Record counts and when each FDA source was last refreshed
Records Count Last refreshed Source as of Status
Recalls 1 Nov 8, 2026 File dated Nov 3, 2026 Current 510(k) clearances 11 Nov 8, 2026 File dated Nov 2, 2026 Current Inspections 2 Nov 13, 2026 Newest record Nov 5, 2026 Current Compliance actions 0 Nov 2, 2026 Newest record Oct 29, 2026 Current
1 recall record on Feb 15, 2017.
Number Class Product Date
Z-1615-2018 Class II Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is… Feb 15, 2017
2 inspections from Jul 4, 2017 to Jul 6, 2017.
Date Site Product Classification FEI
Jul 6, 2017 Anyang, Korea (The Republic Of) Devices Voluntary Action Indicated (VAI) 3013489112 Jul 4, 2017 Seoul, Korea (The Republic Of) Devices Voluntary Action Indicated (VAI) 3007244127
NAI No objectionable conditions or practices were found during the inspection.
VAI Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI Regulatory and/or administrative actions are recommended.
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2 inspected sites, newest inspection first.
Facility Location Inspections Latest
FEI 3013489112 Anyang, Korea (The Republic Of) 1 Jul 6, 2017 FEI 3007244127 Seoul, Korea (The Republic Of) 1 Jul 4, 2017
11 510(k) clearances from Oct 21, 2011 to May 8, 2026.
K-Number Device Date
K252617 MiroCam® Capsule Endoscope System May 8, 2026 K180732 MiroCam Capsule Endoscope System Nov 8, 2018 K170438 MiroCam Capsule Endoscope System Jan 30, 2018 K143663 MiroCam Capsule Endoscope System Mar 17, 2015 K134005 MIROCAM CAPSULE ENDOSCOPE SYSTEM Jul 9, 2014 K140751 MIROCAM CAPSULE ENDOSCOPE SYSTEM Jun 30, 2014 K131131 E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM Jun 21, 2013 K123428 MIROCAM CAPSULE ENDOSCOPE SYSTEM May 20, 2013 K120702 E.G. SCAN II ESPHAGOSCOPE SYSTEM Jun 20, 2012 K111450 MIROCAM CAPSULE ENDOSCOPE SYSTEM May 18, 2012 K111030 E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM Oct 21, 2011
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