Identity
- Trade Name
- Saneso FDA UDI
- Generic Name
- Flexible video colonoscope, reusable FDA UDI
- Device Name
- Saneso Colonoscope 360A. Five cameras with integrated 360 degree field of view, multi-nozzle lens wash system, dedicated tissue wash system, LED lighting, select band and dual band imaging, vertical & horizontal bending radius of 180 degrees & 160 degrees, preserved mechanical characteristics, and a continuous guide view™ of the lumen. FDA UDI
- Model / Reference
- SAN360C-A FDA UDI
- Description
- Saneso Colonoscope 360A. Five cameras with integrated 360 degree field of view, multi-nozzle lens wash system, dedicated tissue wash system, LED lighting, select band and dual band imaging, vertical & horizontal bending radius of 180 degrees & 160 degrees, preserved mechanical characteristics, and a continuous guide view™ of the lumen. FDA UDI
Identifiers
- Primary DI / UDI-DI
- G347SAN360CA0 FDA UDI
- 510(k) Number
- K210052 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
No
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
Dimensions & Sizes
- Size
- Length — 1680 Millimeter FDA UDIOuter Diameter — 15.6 Millimeter FDA UDI
Category: Flexible video colonoscope, reusable
Saneso by Saneso, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video colonoscope, reusable.
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- 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
- FUJIFILM — FUJIFILM Corporation · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
Cleared under the same submission
K210052 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
- Saneso, Inc.
Sources (1)
- FDA UDI 633b968f-95e4-4ffa-80c7-a0a9f674a321 36 fields · synced May 30, 2026