FDA 510(k)

ArtiSential Bipolar Fenestrated Forceps

K番号: K190909 · 2020-02-13

決定日2020-02-13

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 Bipolar Fenestrated Forceps is the device name listed in this FDA 510(k) record. The listed applicant is Livsmed, Inc.. It received FDA 510(k) clearance on 2020-02-13 under 510(k) number K190909. 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 Bipolar Fenestrated Forceps?

ArtiSential Bipolar Fenestrated Forceps is a medical device that received FDA 510(k) clearance on 2020-02-13. The listed applicant is Livsmed, Inc.. The 510(k) number is K190909.

When did ArtiSential Bipolar Fenestrated Forceps receive FDA 510(k) clearance?

ArtiSential Bipolar Fenestrated Forceps received FDA 510(k) clearance on 2020-02-13, under 510(k) number K190909.

Who is the listed applicant for ArtiSential Bipolar Fenestrated Forceps?

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 Bipolar Fenestrated Forceps?

The FDA product code for ArtiSential Bipolar Fenestrated Forceps is GEI.

申請者としてLivsmed, Inc.を記載するその他の記録

すべての12件のデバイスを表示 →

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。