Hobbs Medical TouchSoft Coagulator

Primary DI
M849G11200400
Brand
Hobbs Medical TouchSoft Coagulator
Company
HOBBS MEDICAL, INC.
Model
G1120040
Catalog number
4581-U
Device 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).
Published
2021-04-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093079000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093079000TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-UHobbs Medical, Inc.2010-08-02KNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M849G11200401PackageHIBCC5In Commercial Distribution
M849G11200400PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Argon-enhanced endoscopic electrosurgical electrode, reusableAn invasive, distal component of an argon-enhanced electrosurgical system intended to deliver electrosurgical current within a stream of argon (Ar) gas directly to tissues for cutting/coagulation/ablation during an endoscopic (including laparoscopic, arthroscopic) surgical procedure. It is a long thin device with no controls, typically designed as a coaxial arrangement of a monopolar electrode within an Ar gas delivery tube/sleeve, which requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., rigid laparoscopic electrode, flexible endoscopic probe). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8606845875customerservice@hobbsmedical.com

Regulatory Flags#

DUNS number
076769355
Device count
1
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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