Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Flexible video enteroscope FDA UDI
- Device Name
- The Fujifilm Double Balloon Endoscopes are intended for the visualization of the upper and lower digestive tracts. Specifically, for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, large intestine, and rectum. FDA UDI
- Model / Reference
- EN-530T FDA UDI
- Description
- The Fujifilm Double Balloon Endoscopes are intended for the visualization of the upper and lower digestive tracts. Specifically, for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, large intestine, and rectum. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410331646 FDA UDI
- 510(k) Number
- K143556 FDA UDI
- FDA Product Code
- FDA FDA UDI
- GMDN Term
- Flexible video enteroscope 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
Yes
FDA UDI
Category: Flexible video enteroscope
Fujifilm by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video enteroscope.
- ENTEROSCOPE — PENTAX of America, Inc. · Class II
- EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- ENTEROSCOPE — PENTAX of America, Inc. · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
Cleared under the same submission
K143556 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 a97320b2-8624-4075-a693-f3c9dfc82830 36 fields · synced May 31, 2026