Identity
- Trade Name
- EvoEndo Controller FDA UDI
- Generic Name
- Endoscopic control/video-imaging system FDA UDI
- Device Name
- The Controller of the EvoEndo Endoscopy System translates the images or video captured by the camera at the distal end of the EvoEndo Endoscope to a monitor via an HDMI cable FDA UDI
- Model / Reference
- EE-C FDA UDI
- Description
- The Controller of the EvoEndo Endoscopy System translates the images or video captured by the camera at the distal end of the EvoEndo Endoscope to a monitor via an HDMI cable FDA UDI
Identifiers
- Catalog Number
- 1002 FDA UDI
- Primary DI / UDI-DI
- 00850031897021 FDA UDI
- 510(k) Number
- K213606 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
No
FDA UDI
Category: Endoscopic control/video-imaging system
EvoEndo Controller by Evoendo, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Saneso — Saneso, Inc. · Class II
- Monarch Endoscopy Controller — Auris Health, Inc. · Class II
Cleared under the same submission
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
- Evoendo, Inc.
Sources (1)
- FDA UDI e7f95954-b645-4f6c-9ac4-aa371d926af8 36 fields · synced Jun 8, 2026