Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Flexible video duodenoscope, reusable FDA UDI
- Device Name
- The Fujifilm Duodenoscope Model ED-580XT is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. FDA UDI
- Model / Reference
- ED-580XT FDA UDI
- Description
- The Fujifilm Duodenoscope Model ED-580XT is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410359282 FDA UDI
- FDA Product Code
- FDT FDA UDI
- GMDN Term
- Flexible video duodenoscope, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flexible video duodenoscope, reusable
Fujifilm by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video duodenoscope, reusable.
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- EVIS EXERA II DUODENOVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- VIDEO DUODENOSCOPE — PENTAX of America, Inc. · Class II
- VIDEO DUODENOSCOPE — PENTAX of America, Inc. · Class II
- VIDEO DUODENOSCOPE — PENTAX of America, Inc. · Class II
- EVIS EXERA II DUODENOVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- EVIS EXERA II DUODENOVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- EVIS EXERA III DUODENOVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
Cleared under the same submission
K181745 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- FUJIFILM Corporation
Sources (1)
- FDA UDI eb7e9151-e960-477a-b026-f77d5c7b92d7 36 fields · synced May 29, 2026