Control Handle Left

FDA UDI

Class II (US FDA UDI)

by Dex Surgical

Identity

Trade Name: Control Handle Left FDA UDI
Generic Name: Endoscopic electromechanical surgical system FDA UDI
Device Name: The DEX Device control handle for left handed is comprised of an ergonomic hand piece that can turn on its own axis thanks to the comfort joint. This axis can also allow the user to perform a complete manual prono-supination movement without moving his shoulder. The control handle has command buttons that activate the different degrees of freedom or the Arm. The three axes are motorized: Open/Close, Tilt (Left/Right), Rotation+/Rotation-. FDA UDI
Model / Reference: P-1302 FDA UDI
Description: The DEX Device control handle for left handed is comprised of an ergonomic hand piece that can turn on its own axis thanks to the comfort joint. This axis can also allow the user to perform a complete manual prono-supination movement without moving his shoulder. The control handle has command buttons that activate the different degrees of freedom or the Arm. The three axes are motorized: Open/Close, Tilt (Left/Right), Rotation+/Rotation-. FDA UDI

Identifiers

Primary DI / UDI-DI: 03665772000022 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Endoscopic electromechanical surgical system

Control Handle Left by Dex Surgical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 Unit — 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 79f23874-66cb-45da-876c-3602a067f371 34 fields · synced May 31, 2026