Medical Device Manufacturer · KR , Guro-Gu , Seoul

Intromedic Co., Ltd. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2011

Recent clearances: MiroCam® Capsule Endoscope System, MiroCam Capsule Endoscope System, MiroCam Capsule Endoscope System

11
Total
11
Cleared
0
Denied

FDA 510(k) Regulatory Record - Intromedic Co., Ltd. Gastroenterology & Urology ✕

8 devices
1-8 of 8
Cleared May 08, 2026
MiroCam® Capsule Endoscope System
K252617 · NEZ
Gastroenterology & Urology · 262d
Cleared Nov 08, 2018
MiroCam Capsule Endoscope System
K180732 · NEZ
Gastroenterology & Urology · 233d
Cleared Jan 30, 2018
MiroCam Capsule Endoscope System
K170438 · NEZ
Gastroenterology & Urology · 351d
Cleared Mar 17, 2015
MiroCam Capsule Endoscope System
K143663 · NEZ
Gastroenterology & Urology · 84d
Cleared Jul 09, 2014
MIROCAM CAPSULE ENDOSCOPE SYSTEM
K134005 · NEZ
Gastroenterology & Urology · 194d
Cleared Jun 30, 2014
MIROCAM CAPSULE ENDOSCOPE SYSTEM
K140751 · NEZ
Gastroenterology & Urology · 97d
Cleared May 20, 2013
MIROCAM CAPSULE ENDOSCOPE SYSTEM
K123428 · NEZ
Gastroenterology & Urology · 194d
Cleared May 18, 2012
MIROCAM CAPSULE ENDOSCOPE SYSTEM
K111450 · NEZ
Gastroenterology & Urology · 359d
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