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FDA 510(k)

ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)

K-Number: K250126 · 2025-10-21

ApplicantLivsmed, Inc.
Decision Date2025-10-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) is the device name listed in this FDA 510(k) record. The listed applicant is Livsmed, Inc.. It received FDA 510(k) clearance on 2025-10-21 under 510(k) number K250126. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)?

ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) is a medical device that received FDA 510(k) clearance on 2025-10-21. The listed applicant is Livsmed, Inc.. The 510(k) number is K250126.

When did ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) receive FDA 510(k) clearance?

ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) received FDA 510(k) clearance on 2025-10-21, under 510(k) number K250126.

Who is the listed applicant for ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)?

The FDA 510(k) record lists Livsmed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)?

The FDA product code for ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) is GEI.

Other records listing Livsmed, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241138ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal GeneratorK240657ArtiSential 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-K230498ArtiSential Laparoscopic Instruments-ElectrodesK230539ArtiSential Laparoscopic Instruments-ElectrodesK230499ArtiSential Laparoscopic Instruments-ElectrodesK220384ArtiSential Laparoscopic Instruments-Electrodes

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Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbHK253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology CorporationK251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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