FDA 510(k)

パラゴンT2ウェンドインテグレートケーブル付き

K番号: K153675 · 2016-01-15

決定日2016-01-15

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

Paragon T2 Wand with Integrated Cable is the device name listed in this FDA 510(k) record. The listed applicant is ArthroCare Corporation. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K153675. 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 Paragon T2 Wand with Integrated Cable?

Paragon T2 Wand with Integrated Cable is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is ArthroCare Corporation. The 510(k) number is K153675.

When did Paragon T2 Wand with Integrated Cable receive FDA 510(k) clearance?

Paragon T2 Wand with Integrated Cable received FDA 510(k) clearance on 2016-01-15, under 510(k) number K153675.

Who is the listed applicant for Paragon T2 Wand with Integrated Cable?

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 Paragon T2 Wand with Integrated Cable?

The FDA product code for Paragon T2 Wand with Integrated Cable is GEI.

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

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