Intromedic Co., Ltd.
Medical device manufacturer in Guro-Dong, Guro-Gu, KR.
11510(k) clearances
0PMA approvals
1recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K252617 | MiroCam® Capsule Endoscope SystemNEZ · Special | 05/08/2026SE |
| K180732 | MiroCam Capsule Endoscope SystemNEZ · Traditional | 11/08/2018SE |
| K170438 | MiroCam Capsule Endoscope SystemNEZ · Traditional | 01/30/2018SE |
| K143663 | MiroCam Capsule Endoscope SystemNEZ · Traditional | 03/17/2015SE |
| K134005 | Mirocam Capsule Endoscope SystemNEZ · Traditional | 07/09/2014SE |
| K140751 | Mirocam Capsule Endoscope SystemNEZ · Traditional | 06/30/2014SE |
| K131131 | E.G. Scan(Tm) II Esophagoscope SystemEOX · Special | 06/21/2013SE |
| K123428 | Mirocam Capsule Endoscope SystemNEZ · Traditional | 05/20/2013SE |
| K120702 | E.G. Scan II Esphagoscope SystemEOX · Traditional | 06/20/2012SE |
| K111450 | Mirocam Capsule Endoscope SystemNEZ · Traditional | 05/18/2012SE |
| K111030 | E.G. Scan (TM) Esophagoscope SystemEOX · Traditional | 10/21/2011SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1615-2018 Class II | Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope…When a user switches on MR1100 Receiver, even though the battery was fully charged, the LED was displayed as… | 02/15/2017Terminated |