FDA 510(k)

手術用直接ハンドヘルドラパロスコピック器具

K番号: K193018 · 2019-12-20

決定日2019-12-20

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

Surgical Direct Hand-held Laparoscopic Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Direct, Inc.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K193018. 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 Surgical Direct Hand-held Laparoscopic Instruments?

Surgical Direct Hand-held Laparoscopic Instruments is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Surgical Direct, Inc.. The 510(k) number is K193018.

When did Surgical Direct Hand-held Laparoscopic Instruments receive FDA 510(k) clearance?

Surgical Direct Hand-held Laparoscopic Instruments received FDA 510(k) clearance on 2019-12-20, under 510(k) number K193018.

Who is the listed applicant for Surgical Direct Hand-held Laparoscopic Instruments?

The FDA 510(k) record lists Surgical Direct, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Direct Hand-held Laparoscopic Instruments?

The FDA product code for Surgical Direct Hand-held Laparoscopic Instruments is GEI.

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。

手術用直接ハンドヘルドラパロスコピック器具

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：GEI）

公式ソース