Identity
- Trade Name
- endomina platform FDA UDI
- Generic Name
- Endoscopic overtube, single-use FDA UDI
- Device Name
- endomina platform primary packaging (x1) FDA UDI
- Model / Reference
- endomina platform FDA UDI
- Description
- endomina platform primary packaging (x1) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05425029282018 FDA UDI
- 510(k) Number
- K211309 FDA UDI
- FDA Product Code
- OCW 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Endoscopic overtube, single-use
endomina platform by Endo Tools Therapeutics — 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
- FUJIFILM — FUJIFILM Corporation · Class II
- Guardus — US Endoscopy · Class II
- Guardus — US Endoscopy · Class II
- Pathfinder — Neptune Medical · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- Flexible Overtube — SB-KAWASUMI LABORATORIES, INC. · Class II
- Ancora — ASPERO MEDICAL, INC. · Class II
Cleared under the same submission
K211309 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
- Endo Tools Therapeutics
Sources (1)
- FDA UDI a1ad52c8-daf2-450d-94bd-27e09cc8c4f7 35 fields · synced May 30, 2026