ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH) +7 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K240657

Identifiers

510(k) Number: K240657 FDA 510(k)
FDA Product Code: GEI FDA 510(k)
Models / Variants: ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH) FDA 510(k)
ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH) FDA 510(k)
ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-LH) FDA 510(k)
ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-LH) FDA 510(k)
ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01S-LH) FDA 510(k)
ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-FH) FDA 510(k)
ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-FH) FDA 510(k)
ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L- FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 878.4400 FDA 510(k)
Regulation Number: 878.4400 FDA 510(k)
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Artisential Laparoscopic Instruments-Electrodes are surgical devices designed for use in laparoscopic procedures. These instruments function as electrodes to facilitate surgical tasks during minimally invasive operations.

These devices are supplied by Livsmed, Inc. and have received FDA 510(k) clearance. The product line includes multiple model variations, specifically AMHD01-LH, AMHD01S-LH, AMHD01L-LH, 5AMHD01-LH, 5AMHD01S-LH, AMHD01-FH, AMHD01S-FH, and AMHD01L-.

Frequently asked questions

What are the ArtiSential Laparoscopic Instruments-Electrodes used for?

These devices are designed for use in laparoscopic surgical procedures. They function as electrodes to assist surgeons in performing various surgical tasks during minimally invasive operations.

Which models are included in the ArtiSential instrument line?

The product line includes several model variations to accommodate different surgical needs, specifically AMHD01-LH, AMHD01S-LH, AMHD01L-LH, 5AMHD01-LH, 5AMHD01S-LH, AMHD01-FH, AMHD01S-FH, and AMHD01L-.

What is the regulatory status of these surgical electrodes?

The ArtiSential Laparoscopic Instruments-Electrodes have received FDA 510(k) clearance under K240657, indicating they have been found substantially equivalent to legally marketed predicate devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K240657	Class II	Active

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Manufacturer

Manufacturer: LivsMed Inc.
FDA Applicant: Livsmed, Inc.

Sources (1)

FDA 510(k) K240657 24 fields · synced Sep 27, 2026