Identity
- Trade Name
- Saneso FDA UDI
- Generic Name
- Endoscopic control/video-imaging system FDA UDI
- Device Name
- The Saneso Box incorporates state of the art electronics and software and is the brain behind Saneso’s endoscopy system. It executes all technological innovations incorporated in the Saneso colonoscope and gastroscope. FDA UDI
- Model / Reference
- G347SBA FDA UDI
- Description
- The Saneso Box incorporates state of the art electronics and software and is the brain behind Saneso’s endoscopy system. It executes all technological innovations incorporated in the Saneso colonoscope and gastroscope. FDA UDI
Identifiers
- Primary DI / UDI-DI
- G347SBA0 FDA UDI
- 510(k) Number
- K210052 FDA UDI
- FDA Product Code
- FET FDA UDI
- GMDN Term
- Endoscopic control/video-imaging system 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
Category: Endoscopic control/video-imaging system
Saneso by Saneso, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic control/video-imaging system.
- SPiN Vision Video Processor — VERAN MEDICAL TECHNOLOGIES INC. · Class II
- MAGNIFICATION CONTROLLER — Olympus Medical Systems Corporation · Class II
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- EvoEndo Controller — Evoendo, Inc. · Class II
- Pegasus — A.M. SURGICAL, INC. · Class II
- Monarch Endoscopy Controller — Auris Health, Inc. · 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 c4dfd693-51f9-45eb-ba3b-1d5c31869640 35 fields · synced May 30, 2026