IntroMedic Co., Ltd.
FDA Regulatory Profile
IntroMedic Co., Ltd. appears in FDA public data with 1 recall, 11 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1615-2018, Class II) was initiated on February 15, 2017. Its most recent 510(k) clearance was granted on May 8, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 11
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1615-2018 | Class II | Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is | February 15, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252617 | MiroCam® Capsule Endoscope System | May 8, 2026 |
| K180732 | MiroCam Capsule Endoscope System | November 8, 2018 |
| K170438 | MiroCam Capsule Endoscope System | January 30, 2018 |
| K143663 | MiroCam Capsule Endoscope System | March 17, 2015 |
| K134005 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | July 9, 2014 |
| K140751 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | June 30, 2014 |
| K131131 | E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM | June 21, 2013 |
| K123428 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | May 20, 2013 |
| K120702 | E.G. SCAN II ESPHAGOSCOPE SYSTEM | June 20, 2012 |
| K111450 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | May 18, 2012 |
| K111030 | E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM | October 21, 2011 |