FDA 510(k)

ReNew ドラッグスイッチテープ

K番号: K213127 · 2022-03-02

決定日2022-03-02

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

ReNew Disposable Scissor Tips is the device name listed in this FDA 510(k) record. The listed applicant is Microline Surgical, Inc.. It received FDA 510(k) clearance on 2022-03-02 under 510(k) number K213127. 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 ReNew Disposable Scissor Tips?

ReNew Disposable Scissor Tips is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is Microline Surgical, Inc.. The 510(k) number is K213127.

When did ReNew Disposable Scissor Tips receive FDA 510(k) clearance?

ReNew Disposable Scissor Tips received FDA 510(k) clearance on 2022-03-02, under 510(k) number K213127.

Who is the listed applicant for ReNew Disposable Scissor Tips?

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

What is the FDA product code for ReNew Disposable Scissor Tips?

The FDA product code for ReNew Disposable Scissor Tips is GEI.

申請者としてMicroline Surgical, Inc.を記載するその他の記録

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