FDA.reportPublic FDA data

Artisential Monopolar Hook

Primary DI
08800042703509
Brand
Artisential Monopolar Hook
Company
LIVSMED
Model
AMHR01L-LH
Device description
This device is a sterile, single-use instrument intended to be used with an electrosurgical generator to deliver electrosurgical current in a monopolar configuration for tissue incision and coagulation.
Published
2026-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240657000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240657000ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-Livsmed, Inc.2024-06-06GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800042703509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800042703509088000427035098800042703509

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, monopolar, single-useA sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter8Millimeter
Shaft Length450Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
8335487633infousa@livsmed.com

Regulatory Flags#

DUNS number
688360116
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800042700355Artisential Bipolar Fenestrated ForcepsABF01L-L2026-04-30
08800042700362Artisential Bipolar Fenestrated ForcepsABF01L-F2026-04-30
08800042700454Artisential Bipolar Maryland DissectorABD01L-L2026-04-30
08800042700461Artisential Bipolar Maryland DissectorABD01L-F2026-04-30
08800042700973Artisential Bipolar Precise DissectorABD02L-L2026-04-30
08800042700980Artisential Bipolar Precise DissectorABD02L-F2026-04-30
08800042701185Artisential Bipolar Fenestrated ForcepsABF01-FV2026-04-30
08800042701192Artisential Bipolar Fenestrated ForcepsABF01S-FV2026-04-30
08800042701215Artisential Bipolar Fenestrated ForcepsABF01L-LV2026-04-30
08800042701222Artisential Bipolar Fenestrated ForcepsABF01L-FV2026-04-30
08800042701420Artisential Bipolar Maryland DissectorABD01-FV2026-04-30
08800042701437Artisential Bipolar Maryland DissectorABD01S-FV2026-04-30
08800042701451Artisential Bipolar Maryland DissectorABD01L-LV2026-04-30
08800042701468Artisential Bipolar Maryland DissectorABD01L-FV2026-04-30
08800042701482Artisential Bipolar Precise DissectorABD02-FV2026-04-30
08800042701499Artisential Bipolar Precise DissectorABD02S-FV2026-04-30
08800042701512Artisential Bipolar Precise DissectorABD02L-LV2026-04-30
08800042701529Artisential Bipolar Precise DissectorABD02L-FV2026-04-30
08800042702564Artisential Bipolar Blunt tip DissectorABD04-LV2026-04-30
08800042702588Artisential Bipolar Blunt tip DissectorABD04L-LV2026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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