FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MIROCAM CAPSULE ENDOSCOPE SYSTEM
K Number: K111450
·
Decision May 18, 2012
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
46
Applicant Total
11
Review Days
359
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Basic Information
- Device Name
- MIROCAM CAPSULE ENDOSCOPE SYSTEM
- K Number
- K111450
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intromedic Co., Ltd.
- Date Received
- May 25, 2011
- Decision Date
- May 18, 2012
- Product Code
- NEZ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NEZ | System, Imaging, Gastrointestinal, Wireless, Capsule | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NEZ), ordered by most recent decision date.
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PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
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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 |
| K111030 | E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM | Oct 21, 2011 | Substantially Equivalent |