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FDA 510(k)

ArtiSential Laparoscopic Instrument-Electrodes

K-Number: K200501 · 2020-05-11

ApplicantLivsmed, Inc.
Decision Date2020-05-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ArtiSential Laparoscopic Instrument-Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Livsmed, Inc.. It received FDA 510(k) clearance on 2020-05-11 under 510(k) number K200501. 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 ArtiSential Laparoscopic Instrument-Electrodes?

ArtiSential Laparoscopic Instrument-Electrodes is a medical device that received FDA 510(k) clearance on 2020-05-11. The listed applicant is Livsmed, Inc.. The 510(k) number is K200501.

When did ArtiSential Laparoscopic Instrument-Electrodes receive FDA 510(k) clearance?

ArtiSential Laparoscopic Instrument-Electrodes received FDA 510(k) clearance on 2020-05-11, under 510(k) number K200501.

Who is the listed applicant for ArtiSential Laparoscopic Instrument-Electrodes?

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 ArtiSential Laparoscopic Instrument-Electrodes?

The FDA product code for ArtiSential Laparoscopic Instrument-Electrodes 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.

K250126ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)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-Electrodes

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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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