FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM
K Number: K111030
·
Decision Oct 21, 2011
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
29
Applicant Total
11
Review Days
191
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Basic Information
- Device Name
- E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM
- K Number
- K111030
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4710
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intromedic Co., Ltd.
- Date Received
- April 13, 2011
- Decision Date
- October 21, 2011
- Product Code
- EOX
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EOX | Esophagoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EOX), ordered by most recent decision date.
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PENTAX Medical Video Esophagoscope EE17-J10
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EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
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Other Clearances by Intromedic Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K252617 | MiroCam® Capsule Endoscope System | May 8, 2026 | Substantially Equivalent |
| K180732 | MiroCam Capsule Endoscope System | Nov 8, 2018 | Substantially Equivalent |
| K170438 | MiroCam Capsule Endoscope System | Jan 30, 2018 | Substantially Equivalent |
| K143663 | MiroCam Capsule Endoscope System | Mar 17, 2015 | Substantially Equivalent |
| K134005 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | Jul 9, 2014 | Substantially Equivalent |
| K140751 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | Jun 30, 2014 | Substantially Equivalent |
| K131131 | E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM | Jun 21, 2013 | Substantially Equivalent |
| K123428 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | May 20, 2013 | Substantially Equivalent |
| K120702 | E.G. SCAN II ESPHAGOSCOPE SYSTEM | Jun 20, 2012 | Substantially Equivalent |
| K111450 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | May 18, 2012 | Substantially Equivalent |