FDA.reportPublic FDA data

ArtiSeal Vessel Sealing System - ArtiSeal Instruments

Primary DI
08800042703042
Brand
ArtiSeal Vessel Sealing System - ArtiSeal Instruments
Company
LIVSMED
Model
AS01M
Device description
This device is an electrosurgical instrument intended to be used in conjunction with the ArtiSeal Generator. It delivers high-frequency (RF) energy to the human body. The current flowing into the tissue generates heat through bioimpedance, which is utilized for the ligation (sealing) and division (cutting) of vessels.
Published
2026-04-17
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
K250126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250126000ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc.2025-10-21GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800042703042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800042703042088000427030428800042703042

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, single-useA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery; it is not intended for focal percutaneous ablation. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter8Millimeter
Shaft Length345Millimeter

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
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
08800042706159Artisential Monopolar SpatulaAMT01L-LH2026-06-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434328MillenniumAvalign Technologies, Inc.GEI2026-10-06
B382SD134188100Surgical DirectSurgical Direct, Inc.GEI2026-10-06
B382SD13798330Surgical DirectSurgical Direct, Inc.GEI2026-10-06
00190776433284MillenniumAvalign Technologies, Inc.GEI2026-10-05
00848657078467AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657078474AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083782AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083812AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083843AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083874AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083898AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657084956AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657084963AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657084970AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657087698AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
04953170474958THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
04953170474965THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
04953170474972THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
04953170474989THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
04953170474996THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
04953170475009THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
00190776433062MillenniumAvalign Technologies, Inc.GEI2026-10-01
10884521740150LigaSureCovidien LPGEI2026-10-01
00190776432980MillenniumAvalign Technologies, Inc.GEI2026-09-30
B382SD070823101310Surgical DirectSurgical Direct, Inc.GEI2026-09-30
10884450452353STAR™Merit Medical Systems, Inc.GEI2026-09-29
00190776432645MillenniumAvalign Technologies, Inc.GEI2026-09-28
00197998302718Solventum™Solventum US LLCGEI2026-09-25
00724995269586Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269951Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25