FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Endoscope Model EG-580UT and Endoscope Model EG-580UR
K Number: K221952
·
Decision Aug 4, 2022
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
42
Applicant Total
64
Review Days
30
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Basic Information
- Device Name
- Endoscope Model EG-580UT and Endoscope Model EG-580UR
- K Number
- K221952
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fujifilm Corporation
- Date Received
- July 5, 2022
- Decision Date
- August 4, 2022
- Product Code
- ODG
- 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 |
|---|---|---|---|
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
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