Intromedic Co., Ltd. is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
Intromedic Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: MiroCam® Capsule Endoscope System, MiroCam Capsule Endoscope System, MiroCam Capsule Endoscope System
11
Total
11
Cleared
0
Denied
Intromedic Co., Ltd. has 11 FDA 510(k) cleared gastroenterology & urology devices. Based in Guro-Gu , Seoul, KR.
Latest FDA clearance: May 2026. Active since 2011.
Browse the complete list of FDA 510(k) cleared gastroenterology & urology devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Acts as regulatory consultant.
FDA 510(k) Regulatory Record - Intromedic Co., Ltd.
11 devices
Cleared
May 08, 2026
MiroCam® Capsule Endoscope System
Gastroenterology & Urology
262d
Cleared
Nov 08, 2018
MiroCam Capsule Endoscope System
Gastroenterology & Urology
233d
Cleared
Jan 30, 2018
MiroCam Capsule Endoscope System
Gastroenterology & Urology
351d
Cleared
Mar 17, 2015
MiroCam Capsule Endoscope System
Gastroenterology & Urology
84d
Cleared
Jul 09, 2014
MIROCAM CAPSULE ENDOSCOPE SYSTEM
Gastroenterology & Urology
194d
Cleared
Jun 30, 2014
MIROCAM CAPSULE ENDOSCOPE SYSTEM
Gastroenterology & Urology
97d
Cleared
Jun 21, 2013
E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM
Ear, Nose, Throat
60d
Cleared
May 20, 2013
MIROCAM CAPSULE ENDOSCOPE SYSTEM
Gastroenterology & Urology
194d
Cleared
Jun 20, 2012
E.G. SCAN II ESPHAGOSCOPE SYSTEM
Ear, Nose, Throat
104d
Cleared
May 18, 2012
MIROCAM CAPSULE ENDOSCOPE SYSTEM
Gastroenterology & Urology
359d
Cleared
Oct 21, 2011
E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM
Ear, Nose, Throat
191d