FDA.reportPublic FDA data

Artisential Monopolar Spatula

Primary DI
08800042706159
Brand
Artisential Monopolar Spatula
Company
LIVSMED
Model
AMT01L-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
2026-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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
08800042706159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800042706159088000427061598800042706159

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 Diameter0
Shaft Length0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Storage Environment Humidity00

Contacts#

Phone, Email table
PhoneEmail
8335487633infousa@livsmed.com

Regulatory Flags#

DUNS number
688360116
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800042706166Artisential Clip Applier LargeACA03-PG2026-07-10
08800042706173Artisential Clip Applier LargeACA03S-PG2026-07-10
08800042706111Artisential Clip Applier LargeACA03-LV2026-06-05
08800042706128Artisential Clip Applier LargeACA03-FV2026-06-05
08800042706135Artisential Clip Applier LargeACA03S-LV2026-06-05
08800042706142Artisential Clip Applier LargeACA03S-FV2026-06-05
08809756910067Artisential Monopolar SpatulaAMT01L-LH2026-04-28
08809756910081Artisential Clip Applier LargeACA03-FV2026-04-21
08809756910104Artisential Clip Applier LargeACA03S-FV2026-04-21
08809756910074Artisential Clip Applier LargeACA03-LV2025-09-08
08809756910098Artisential Clip Applier LargeACA03S-LV2025-09-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776439774MilleniumAvalign Technologies, Inc.GEI2026-10-26
10884521783829LigaSureCovidien LPGEI2026-10-23
00190776436858MillenniumAvalign Technologies, Inc.GEI2026-10-22
B382SD77105560Surgical DirectSurgical Direct, Inc.GEI2026-10-22
00190776435752MillenniumAvalign Technologies, Inc.GEI2026-10-21
00190776435769MillenniumAvalign Technologies, Inc.GEI2026-10-21
00841019124192KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-21
B108499AP1MRA1MUS00Large applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
00190776435288MillenniumAvalign Technologies, Inc.GEI2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
00860016247000Super PencilRF KINETICS LLCGEI2026-10-17
00860016247017Super PencilRF KINETICS LLCGEI2026-10-17
00860016247024Super PencilRF KINETICS LLCGEI2026-10-17
00860016247031Super PencilRF KINETICS LLCGEI2026-10-17
00841019124017KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124024KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124048KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124079KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124086KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124093KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124109KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16