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Monopolar Hook

FDA UDI

Class II (US FDA UDI)

by Human Xtensions , Ltd.

Identity

Trade Name
Monopolar Hook FDA UDI
Generic Name
Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
Device Name
The Monopolar Hook is a single-use sterile electrosurgical electrode for use with the HandXTM device. The Monopolar Hook is connected to the HandX device and transmits the HandX device motors’ rotation in order to articulate the movement of the end effector of the Monopolar Hook. It is designed to address surgeons’ needs relating to the application of monopolar diathermy for various surgical purposes. The Monopolar Hook is connected to a standard electrosurgical unit via a standard generator cable. FDA UDI
Model / Reference
20-30-044-01 FDA UDI
Description
The Monopolar Hook is a single-use sterile electrosurgical electrode for use with the HandXTM device. The Monopolar Hook is connected to the HandX device and transmits the HandX device motors’ rotation in order to articulate the movement of the end effector of the Monopolar Hook. It is designed to address surgeons’ needs relating to the application of monopolar diathermy for various surgical purposes. The Monopolar Hook is connected to a standard electrosurgical unit via a standard generator cable. FDA UDI

Identifiers

Catalog Number
20-30-073-01 FDA UDI
Primary DI / UDI-DI
07290017376080 FDA UDI
510(k) Number
K203603 FDA UDI
FDA Product Code
GCJ FDA UDI
GEI FDA UDI
GMDN Term
Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Endoscopic electrosurgical electrode, monopolar, single-use

Monopolar Hook by Human Xtensions , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic electrosurgical electrode, monopolar, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Human Xtensions , Ltd.

Sources (1)

  • FDA UDI adc7cc3b-f572-487f-b83a-47bd35a257ff 36 fields · synced Jun 1, 2026