Identity
- Trade Name
- Zsquare ENT-Flex Console FDA UDI
- Generic Name
- Endoscopic video image processing/light source system FDA UDI
- Device Name
- square ENT-Flex Console. Reusable. To be used with Zsquare ENT-flex Single-Use Shell and Zsquare ENT-Flex Imaging Core. Contains illumination source, cart, foot switch, keyboard, monitor and CCU with accompanying software. Enables live imaging, snapshot and video recording. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- square ENT-Flex Console. Reusable. To be used with Zsquare ENT-flex Single-Use Shell and Zsquare ENT-Flex Imaging Core. Contains illumination source, cart, foot switch, keyboard, monitor and CCU with accompanying software. Enables live imaging, snapshot and video recording. FDA UDI
Identifiers
- Catalog Number
- 100000US FDA UDI
- Primary DI / UDI-DI
- 07290019505044 FDA UDI
- 510(k) Number
- K220004 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Endoscopic video image processing/light source system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4760 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/light source system
Zsquare ENT-Flex Console by Zsquare Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K220004 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
- Zsquare Ltd
Sources (1)
- FDA UDI 07b16803-440b-48d8-a451-94453f9c6570 36 fields · synced May 30, 2026