FDA 510(k)

Quiver Laparoscopic Extendable

K番号: K153472 · 2016-06-23

決定日2016-06-23

製品コードHAM

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

Quiver Laparoscopic Extendable is the device name listed in this FDA 510(k) record. The listed applicant is Itl Corporation Pty, Ltd.. It received FDA 510(k) clearance on 2016-06-23 under 510(k) number K153472. The device is classified under product code HAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Quiver Laparoscopic Extendable?

Quiver Laparoscopic Extendable is a medical device that received FDA 510(k) clearance on 2016-06-23. The listed applicant is Itl Corporation Pty, Ltd.. The 510(k) number is K153472.

When did Quiver Laparoscopic Extendable receive FDA 510(k) clearance?

Quiver Laparoscopic Extendable received FDA 510(k) clearance on 2016-06-23, under 510(k) number K153472.

Who is the listed applicant for Quiver Laparoscopic Extendable?

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

What is the FDA product code for Quiver Laparoscopic Extendable?

The FDA product code for Quiver Laparoscopic Extendable is HAM.

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