Identity
- Trade Name
- EyeRSurgN FDA UDI
- Generic Name
- Endoscopic video image processing unit FDA UDI
- Device Name
- 4K 4-Chip Camera Console FDA UDIEyeRSurgN Camera System FDA UDI
- Model / Reference
- 10010 FDA UDI
- Description
- 4K 4-Chip Camera Console FDA UDIEyeRSurgN Camera System FDA UDI
Identifiers
- Primary DI / UDI-DI
- G465100100 FDA UDIE30000019 FDA UDI
- 510(k) Number
- K213943 FDA UDI
- FDA Product Code
- OWN FDA UDI
- GMDN Term
- Endoscopic video image processing unit 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic video image processing unit
EyeRSurgN by Smartsurgn Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic video image processing unit.
- Pixa — SANTA BARBARA IMAGING SYSTEMS, INC. · Class II
- ILO — ILO electronic GmbH · Class I
- AURORA® Surgiscope® — Integra Lifesciences Corp. · Class II
- VIDEO PROCESSOR — PENTAX of America, Inc. · Class II
- Digital Video Processor — Hunan Vathin Medical Instrument Co., Ltd · Class II
- ILO — ILO electronic GmbH · Class I
- 3NT Video Console — 3nt Medical , Ltd. · Class II
- HDMI cable — MacroLux Medical Technology Co., Ltd. · Class II
Cleared under the same submission
K213943 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smartsurgn Inc.
Sources (2)
- FDA UDI fe9823cc-8ae2-4fc4-ad79-53497275a153 34 fields · synced May 31, 2026
- FDA UDI 4b2c96ac-7618-481c-9ab1-f7d956600566 34 fields · synced May 27, 2026