FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T
K Number: K253137
·
Decision Jun 16, 2026
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
238
Applicant Total
64
Review Days
264
Basic Information
- Device Name
- FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T
- K Number
- K253137
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fujifilm Corporation
- Date Received
- September 25, 2025
- Decision Date
- June 16, 2026
- Product Code
- EOQ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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