Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Flexible video colonoscope, reusable FDA UDI
- Device Name
- This product is intended to be used in conjunction with applicable model FUJIFILM endoscopes having a water jet (WJ) channel to deliver sterile water or fluids. Do not use this product for any other purpose. FDA UDI
- Model / Reference
- JT-500 FDA UDI
- Description
- This product is intended to be used in conjunction with applicable model FUJIFILM endoscopes having a water jet (WJ) channel to deliver sterile water or fluids. Do not use this product for any other purpose. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410195743 FDA UDI
- 510(k) Number
- K112391 FDA UDI
- FDA Product Code
- FDF FDA UDI
- GMDN Term
- Flexible video colonoscope, 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Flexible video colonoscope, reusable
Fujifilm by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video colonoscope, reusable.
- PENTAX — HOYA CORPORATION · Class II
- VIDEO COLONOSCOPE — PENTAX of America, Inc. · Class II
- Endoch — Endoch Inc · Class II
- VIDEO COLONOSCOPE — PENTAX of America, Inc. · Class II
- PENTAX — HOYA CORPORATION · Class II
- EVIS EXERA lll COLONOVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- VIDEO COLONOSCOPE — PENTAX of America, Inc. · Class II
- VIDEO COLONOSCOPE — PENTAX of America, Inc. · Class II
Cleared under the same submission
K112391 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 db5781e0-0d32-40ca-a014-75ebdff3c35e 36 fields · synced May 29, 2026