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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 a medical device manufactured by Livsmed, Inc.. It received FDA 510(k) clearance on 2025-10-21 under approval 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. It is manufactured by Livsmed, Inc.. The 510(k) number is K250126.

When was ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) approved by the FDA?

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

What company makes ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)?

ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) is manufactured by Livsmed, Inc..

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.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT06249776 Gravity Stent-Retriever System For Reperfusion Of Large Vessel Occlusion Stroke Trial COMPLETED NCT07595666 Comparison of NeuroEXPLORER PET/CT Versus Standard-of-care PET/CT of the Head and Neck Region. ENROLLING_BY_INVITATION NCT07596550 Comparative Study of Augmented Reality and Virtual Reality in Music Therapy Interventions for Individuals With Cerebral Palsy NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026)

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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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