Identity
- Trade Name
- WiScope® FDA UDI
- Generic Name
- Endoscopic video image processing unit FDA UDI
- Device Name
- Image System, adapting to a monitor of 16:9 aspect ratio. FDA UDI
- Model / Reference
- OTU-A FDA UDI
- Description
- Image System, adapting to a monitor of 16:9 aspect ratio. FDA UDI
Identifiers
- Catalog Number
- 4201A0401T FDA UDI
- Primary DI / UDI-DI
- 00850023925114 FDA UDI
- 510(k) Number
- K181977 FDA UDI
- FDA Product Code
- FGB 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
WiScope® by Otu Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 3NT Video Console — 3nt Medical , Ltd. · Class II
- HDMI cable — MacroLux Medical Technology Co., Ltd. · 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
- Otu Medical Inc.
Sources (1)
- FDA UDI 0017f2ec-2f32-4453-a60f-b42ce48c40ea 35 fields · synced Jun 8, 2026