FDA 510(k)

Ambient HipVac 50 Wand with Integrated Finger Switches

K番号: K161481 · 2016-10-21

決定日2016-10-21

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

Ambient HipVac 50 Wand with Integrated Finger Switches is the device name listed in this FDA 510(k) record. The listed applicant is ArthroCare Corporation. It received FDA 510(k) clearance on 2016-10-21 under 510(k) number K161481. 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 Ambient HipVac 50 Wand with Integrated Finger Switches?

Ambient HipVac 50 Wand with Integrated Finger Switches is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is ArthroCare Corporation. The 510(k) number is K161481.

When did Ambient HipVac 50 Wand with Integrated Finger Switches receive FDA 510(k) clearance?

Ambient HipVac 50 Wand with Integrated Finger Switches received FDA 510(k) clearance on 2016-10-21, under 510(k) number K161481.

Who is the listed applicant for Ambient HipVac 50 Wand with Integrated Finger Switches?

The FDA 510(k) record lists ArthroCare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ambient HipVac 50 Wand with Integrated Finger Switches?

The FDA product code for Ambient HipVac 50 Wand with Integrated Finger Switches is GEI.

申請者としてArthroCare Corporationを記載するその他の記録

K254122FLOW FLEXTEND Wand（72290039）K253680LYNX COBLATION 喉頭ウェンド（72290254）K240964FLOW 90? Wand K232290インテリオシフトシステム K230914ARIS¿ COBLATION¿鼻中隔縮小ウェンド（72290113）；WEREWOLF COBLATIONシステム（72290144）；WEREWOLF+ COBLATIONシステム（72290146）K220563Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System

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