ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)

Q: What is the product code of K250126?

The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.

FDA 510(k) K250126 · Livsmed, Inc.

Substantially Equivalent

510(k) numberK250126

Submission

Device name: ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)
Applicant: Livsmed, Inc.
Seongnam-Si, KR
Received: January 17, 2025
Decision date: October 21, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GEI – Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.4400
Specialty: General, Plastic Surgery

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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More from Stryker Sustainability Solutions

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K240657	ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic…GEI · Traditional	06/06/2024SE
K230498	ArtiSential Laparoscopic Instruments-ElectrodesGEI · Traditional	06/05/2023SE
K230539	ArtiSential Laparoscopic Instruments-ElectrodesGEI · Traditional	04/27/2023SE
K230499	ArtiSential Laparoscopic Instruments-ElectrodesGEI · Traditional	04/26/2023SE
K220384	ArtiSential Laparoscopic Instruments-ElectrodesGEI · Special	02/24/2022SE
K212500	ArtiSential TrocarGCJ · Traditional	12/03/2021SE
K203580	ArtiSential Laparoscopic Instruments-ElectrodesGEI · Traditional	04/30/2021SE
K200875	ArtiSential Laparoscopic Instruments - ElectrodesGEI · Special	06/17/2020SE
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Questions and answers

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

ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) (K250126) received a 510(k) decision of Substantially Equivalent on October 21, 2025, 277 days after the submission was received.

What is the product code of K250126?

The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.