Company · KR
Intromedic Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2026. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 8, 2026 | K252617 | MiroCam® Capsule Endoscope System Intromedic Co., Ltd., KR | NEZ |
| Nov 8, 2018 | K180732 | MiroCam Capsule Endoscope System Intromedic Co., Ltd., KR | NEZ |
| Jan 30, 2018 | K170438 | MiroCam Capsule Endoscope System Intromedic Co., Ltd., KR | NEZ |
| Mar 17, 2015 | K143663 | MiroCam Capsule Endoscope System Intromedic Co., Ltd., KR | NEZ |
| Jul 9, 2014 | K134005 | MIROCAM CAPSULE ENDOSCOPE SYSTEM Intromedic Co., Ltd., KR | NEZ |
| Jun 30, 2014 | K140751 | MIROCAM CAPSULE ENDOSCOPE SYSTEM Intromedic Co., Ltd., KR | NEZ |
| Jun 21, 2013 | K131131 | E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM Intromedic Co., Ltd. | EOX |
| May 20, 2013 | K123428 | MIROCAM CAPSULE ENDOSCOPE SYSTEM Intromedic Co., Ltd., KR | NEZ |
| Jun 20, 2012 | K120702 | E.G. SCAN II ESPHAGOSCOPE SYSTEM Intromedic Co., Ltd., KR | EOX |
| May 18, 2012 | K111450 | MIROCAM CAPSULE ENDOSCOPE SYSTEM Intromedic Co., Ltd. | NEZ |
| Oct 21, 2011 | K111030 | E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM Intromedic Co., Ltd., KR | EOX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2017 | IntroMedic Co., Ltd. Miriam Capsule Endoscope System. Model MR1100
Product Usage:
MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abn Terminated |
NEZ | K123428 |