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Hobbs Medical TouchSoft Coagulator

FDA UDI

Class II (US FDA UDI)

by Hobbs Medical, Inc.

Identity

Trade Name
Hobbs Medical TouchSoft Coagulator FDA UDI
Generic Name
Inert gas-enhanced endoscopic electrosurgical electrode, reusable FDA UDI
Device Name
An assembly of devices that uses radio-frequency (RF) alternating current to develop heat directly within soft-tissue cells (thermodynamic) for cutting and coagulating tissue within a shield of argon (Ar) gas during surgery. It typically includes a generator, a single-use/reusable electrode handpiece with monopolar electrodes, connecting cables, foot-switch, and an argon gas supply system [housed in a separate trolley (cart) or incorporated into the system generator]. The current forms an ionized channel or arc within the argon shield which lessens the charring of tissue and provides rapid, uniform coagulation over large bleeding surfaces (e.g., capillary beds). FDA UDI
Model / Reference
G1120040 FDA UDI
Description
An assembly of devices that uses radio-frequency (RF) alternating current to develop heat directly within soft-tissue cells (thermodynamic) for cutting and coagulating tissue within a shield of argon (Ar) gas during surgery. It typically includes a generator, a single-use/reusable electrode handpiece with monopolar electrodes, connecting cables, foot-switch, and an argon gas supply system [housed in a separate trolley (cart) or incorporated into the system generator]. The current forms an ionized channel or arc within the argon shield which lessens the charring of tissue and provides rapid, uniform coagulation over large bleeding surfaces (e.g., capillary beds). FDA UDI

Identifiers

Catalog Number
4581-U FDA UDI
Primary DI / UDI-DI
M849G11200400 FDA UDI
510(k) Number
K093079 FDA UDI
FDA Product Code
KNS FDA UDI
GMDN Term
Inert gas-enhanced endoscopic electrosurgical electrode, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4300 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

Yes

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

Yes

FDA UDI

Category: Inert gas-enhanced endoscopic electrosurgical electrode, reusable

Hobbs Medical TouchSoft Coagulator by Hobbs Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Inert gas-enhanced endoscopic electrosurgical electrode, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hobbs Medical, Inc.

Sources (1)

  • FDA UDI 7e99beba-c485-46b2-a500-4b4dca609f21 36 fields · synced May 29, 2026