FDA 510(k)

オーロラ手術鏡システム（Surgiscope）、オーロラ手術鏡システム（画像制御ボックス）

K番号: K201840 · 2020-11-04

決定日2020-11-04

製品コードGWG

諮問委員会Please provide the source text to translate.

決定大幅同等

医療機器の概要

Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) is the device name listed in this FDA 510(k) record. The listed applicant is Rebound Therapeutics. It received FDA 510(k) clearance on 2020-11-04 under 510(k) number K201840. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)?

Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) is a medical device that received FDA 510(k) clearance on 2020-11-04. The listed applicant is Rebound Therapeutics. The 510(k) number is K201840.

When did Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) receive FDA 510(k) clearance?

Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) received FDA 510(k) clearance on 2020-11-04, under 510(k) number K201840.

Who is the listed applicant for Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)?

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

What is the FDA product code for Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)?

The FDA product code for Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) is GWG.

申請者としてRebound Therapeuticsを記載するその他の記録

K203745AURORA Evacuator +Coag K201637オーロラエヴァキュエーター +Coag K191861オーロラ手術鏡システム K190075オーロラエヴァキュエーター K180372オーロラエヴァキュエーター

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