Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Endoscopic overtube, single-use FDA UDI
- Device Name
- This product is intended to be used in combination with an endoscope to assist endoscopic insertion into the body. Never use this product for any other purpose. This product is intended for use in medical facilities by medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments. FDA UDI
- Model / Reference
- TR-1208A FDA UDI
- Description
- This product is intended to be used in combination with an endoscope to assist endoscopic insertion into the body. Never use this product for any other purpose. This product is intended for use in medical facilities by medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410484687 FDA UDI
- 510(k) Number
- K230752 FDA UDI
- FDA Product Code
- FED FDA UDI
- GMDN Term
- Endoscopic overtube, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic overtube, single-use
Fujifilm by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic overtube, single-use.
- Pathfinder® — Neptune Medical · Class II
- Guardus — US Endoscopy · Class II
- Guardus — US Endoscopy · Class II
- endomina platform — Endo Tools Therapeutics · Class II
- Pathfinder — Neptune Medical · Class II
- Flexible Overtube — SB-KAWASUMI LABORATORIES, INC. · Class II
- Ancora — ASPERO MEDICAL, INC. · Class II
- Guardus — US Endoscopy · Class II
Cleared under the same submission
K230752 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 17f51cba-a75b-4e20-ae9c-e9d2f92615ac 36 fields · synced May 30, 2026