Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Endoscopic overtube, single-use FDA UDI
- Device Name
- These sterile Over-tubes are intended to be used as accessories with the FUJINON/ FUJIFILM Double Balloon Endoscopes cleared for use with Over-tubes. The Over-tubes are used to assist with the movement of the scopes inside the upper or lower digestive tract. This product is not intended for use for any neonates, infants or children. FDA UDI
- Model / Reference
- TS-12140 FDA UDI
- Description
- These sterile Over-tubes are intended to be used as accessories with the FUJINON/ FUJIFILM Double Balloon Endoscopes cleared for use with Over-tubes. The Over-tubes are used to assist with the movement of the scopes inside the upper or lower digestive tract. This product is not intended for use for any neonates, infants or children. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410331493 FDA UDI
- 510(k) Number
- K091773 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
Yes
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
No
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
K091773 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 6efe2ca8-e5e3-45d9-b7f2-de929ac4c3d2 36 fields · synced Jun 1, 2026