Identity
- Trade Name
- Control Unit FDA UDI
- Generic Name
- Endoscopic electromechanical surgical system FDA UDI
- Device Name
- The console or control unit contains the DEX Device operating system. The front surface contains indicator lights, buttons, an emergency stop button and a connection port FDA UDI
- Model / Reference
- E-1301 FDA UDI
- Description
- The console or control unit contains the DEX Device operating system. The front surface contains indicator lights, buttons, an emergency stop button and a connection port FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03665772000008 FDA UDI
- 510(k) Number
- K191878 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Endoscopic electromechanical surgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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 electromechanical surgical system
Control Unit by Dex Surgical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endoscopic electromechanical surgical system.
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- HandX — Human Xtensions , Ltd. · Class II
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Cleared under the same submission
K191878 also covers:
- Arm Monopolar Maryland — Dex Surgical
- Arm Monopolar hook — Dex Surgical
- Arm Monopolar scissors — Dex Surgical
- Arm Needle holder — Dex Surgical
- Control Handle Left — Dex Surgical
- Control handle — Dex Surgical
- Monopolar protection sleeve — Dex Surgical
- Protection sleeve — Dex Surgical
- Sleeve applicator tool — Dex Surgical
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
- Dex Surgical
Sources (1)
- FDA UDI 3bda95f7-eb3f-4248-8879-f52d8c6fd451 34 fields · synced May 30, 2026