FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L
K Number: K243261
·
Decision May 23, 2025
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
108
Applicant Total
14
Review Days
220
Basic Information
- Device Name
- FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L
- K Number
- K243261
- 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
- October 15, 2024
- Decision Date
- May 23, 2025
- Product Code
- FDF
- 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 |
|---|---|---|---|
| FDF | Colonoscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Fujifilm Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K243260 | FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R | Apr 11, 2025 | Substantially Equivalent |
| K243091 | Over-tube (TR-1108A) | Nov 1, 2024 | Substantially Equivalent |
| K242779 | Hood (DH-083ST) | Oct 11, 2024 | Substantially Equivalent |
| K240142 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP | Sep 4, 2024 | Substantially Equivalent |
| K214089 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 | Jun 3, 2022 | Substantially Equivalent |
| K203103 | Synapse 3D, Synapse 3D Base Tools v6.1 | Feb 9, 2021 | Substantially Equivalent |
| K203028 | FUJIFILM Distal End Cap | Oct 30, 2020 | Substantially Equivalent |
| K202130 | FUJIFILM Video Laparoscope | Aug 20, 2020 | Substantially Equivalent |
| K192440 | FDR SE Lite | Nov 1, 2019 | Substantially Equivalent |
| K191544 | Synapse 3D Blood Flow Analysis | Oct 18, 2019 | Substantially Equivalent |