FDA 510(k)

LevaLap 腹腔鏡アクセス装置

K番号: K212786 · 2022-02-23

申請者Core Access Surgical Technologies, Inc.

決定日2022-02-23

製品コードHIF

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OB [翻訳] OB

決定大幅同等

医療機器の概要

LevaLap Laparoscopic Access Device is the device name listed in this FDA 510(k) record. The listed applicant is Core Access Surgical Technologies, Inc.. It received FDA 510(k) clearance on 2022-02-23 under 510(k) number K212786. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the LevaLap Laparoscopic Access Device?

LevaLap Laparoscopic Access Device is a medical device that received FDA 510(k) clearance on 2022-02-23. The listed applicant is Core Access Surgical Technologies, Inc.. The 510(k) number is K212786.

When did LevaLap Laparoscopic Access Device receive FDA 510(k) clearance?

LevaLap Laparoscopic Access Device received FDA 510(k) clearance on 2022-02-23, under 510(k) number K212786.

Who is the listed applicant for LevaLap Laparoscopic Access Device?

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

What is the FDA product code for LevaLap Laparoscopic Access Device?

The FDA product code for LevaLap Laparoscopic Access Device is HIF.

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LevaLap 腹腔鏡アクセス装置

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：HIF）

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