FDA 510(k)

ArtiSential 腹腔鏡器械-Electrodes

K番号: K230499 · 2023-04-26

決定日2023-04-26

製品コードGEI

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

ArtiSential Laparoscopic Instruments-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 2023-04-26 under 510(k) number K230499. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the ArtiSential Laparoscopic Instruments-Electrodes?

ArtiSential Laparoscopic Instruments-Electrodes is a medical device that received FDA 510(k) clearance on 2023-04-26. The listed applicant is Livsmed, Inc.. The 510(k) number is K230499.

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

ArtiSential Laparoscopic Instruments-Electrodes received FDA 510(k) clearance on 2023-04-26, under 510(k) number K230499.

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

The FDA product code for ArtiSential Laparoscopic Instruments-Electrodes is GEI.

申請者としてLivsmed, Inc.を記載するその他の記録

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