FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FUJIFILM Stiffening Wire Device (SW-2000)
K Number: K251204
·
Decision Sep 26, 2025
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
19
Applicant Total
13
Review Days
161
Basic Information
- Device Name
- FUJIFILM Stiffening Wire Device (SW-2000)
- K Number
- K251204
- 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 Healthcare Americas Corporation
- Date Received
- April 18, 2025
- Decision Date
- September 26, 2025
- Product Code
- FDA
- 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 |
|---|---|---|---|
| FDA | Enteroscope And Accessories | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by FUJIFILM Healthcare Americas Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K261713 | Synapse PACS (7.6.0) | Jun 18, 2026 | Substantially Equivalent |
| K243647 | Synapse PACS (7.5) | Jun 30, 2025 | Substantially Equivalent |
| K233321 | Double Balloon Endoscope EN-840T, Over-tube TS-1214C | Jun 13, 2024 | Substantially Equivalent |
| K233629 | APERTO Lucent MRI System | May 10, 2024 | Substantially Equivalent |
| K233687 | ECHELON Synergy V10.0 | May 3, 2024 | Substantially Equivalent |
| K233583 | FCT iSTREAM Phase 1 | Apr 26, 2024 | Substantially Equivalent |
| K240075 | FUJIFILM Endoscope Model EB-710XT | Feb 7, 2024 | Substantially Equivalent |
| K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | Dec 13, 2023 | Substantially Equivalent |
| K231941 | ARIETTA x10 | Nov 20, 2023 | Substantially Equivalent |
| K231574 | Scenaria View 4.2 | Oct 12, 2023 | Substantially Equivalent |