FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit
K Number: K250550
·
Decision Feb 17, 2026
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
74
Applicant Total
64
Review Days
357
Basic Information
- Device Name
- FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit
- K Number
- K250550
- 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
- February 25, 2025
- Decision Date
- February 17, 2026
- Product Code
- FDS
- 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 |
|---|---|---|---|
| FDS | Gastroscope 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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| K253568 | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR | Feb 6, 2026 | Substantially Equivalent |
| 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 |