FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000
K Number: K251861
·
Decision Mar 9, 2026
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
34
Applicant Total
64
Review Days
265
Basic Information
- Device Name
- FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000
- K Number
- K251861
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fujifilm Corporation
- Date Received
- June 17, 2025
- Decision Date
- March 9, 2026
- Product Code
- FDT
- 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 |
|---|---|---|---|
| FDT | Duodenoscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Fujifilm Corporation
| K Number | Device Name | ||
|---|---|---|---|
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| K250863 | FUJIFILM Ultrasonic Endoscope EB-710US | Dec 12, 2025 | Substantially Equivalent |
| K251386 | ECHELON Synergy | Sep 17, 2025 | Substantially Equivalent |
| K244017 | FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 | Jun 13, 2025 | Substantially Equivalent |
| K243512 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP | Jun 10, 2025 | Substantially Equivalent |