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510(k) K200501

ArtiSential Laparoscopic Instrument-Electrodes by Livsmed, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2020
Date Received
February 28, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

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).

Other clearances by Livsmed, Inc.

  • K250126 — ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) (October 21, 2025)
  • K241138 — ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing Sys (November 15, 2024)
  • K240657 — ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparos (June 6, 2024)
  • K230498 — ArtiSential Laparoscopic Instruments-Electrodes (June 5, 2023)
  • K230539 — ArtiSential Laparoscopic Instruments-Electrodes (April 27, 2023)
  • K230499 — ArtiSential Laparoscopic Instruments-Electrodes (April 26, 2023)
  • K220384 — ArtiSential Laparoscopic Instruments-Electrodes (February 24, 2022)
  • K212500 — ArtiSential Trocar (December 3, 2021)
  • K203580 — ArtiSential Laparoscopic Instruments-Electrodes (April 30, 2021)
  • K200875 — ArtiSential Laparoscopic Instruments - Electrodes (June 17, 2020)

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