FDA 510(k)

StitchKit V-Loc 90、StitchKit V-Loc 180、StitchKit Quill PDO

K番号: K173874 · 2018-05-04

決定日2018-05-04

製品コードGAM

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

StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO is the device name listed in this FDA 510(k) record. The listed applicant is Origami Surgical, LLC. It received FDA 510(k) clearance on 2018-05-04 under 510(k) number K173874. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO?

StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO is a medical device that received FDA 510(k) clearance on 2018-05-04. The listed applicant is Origami Surgical, LLC. The 510(k) number is K173874.

When did StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO receive FDA 510(k) clearance?

StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO received FDA 510(k) clearance on 2018-05-04, under 510(k) number K173874.

Who is the listed applicant for StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO?

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

What is the FDA product code for StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO?

The FDA product code for StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO is GAM.

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StitchKit V-Loc 90、StitchKit V-Loc 180、StitchKit Quill PDO

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：GAM）

公式ソース