FDA 510(k)

ReNew可重用剪刀尖

K 號：K213127 · 2022-03-02

決定日期2022-03-02

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Microline Surgical, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K234147ReNew XR 手柄，25cm，附參考標記（3943M）；ReNew XR 手柄，34cm，附參考標記（3941M）；ReNew XR 手柄，42cm，附參考標記（3942M）；ReNew XR 手柄，可調節螺紐，25cm，附參考標記（3946M）；ReNew XR 手柄，可調節螺紐，34cm，附參考標記（3944M）；ReNew XR 手柄，可調節螺紐，42cm，附參考標記（3945M）K201884ReNew XR 手柄，ReNew XR 手柄 34cm，ReNew XR 手柄 42cm，ReNew XR 手柄 25cm，可調節式 ReNew XR 手柄 34cm K160706ReNew V 手術刀柄腹腔鏡器械 K152745ReNew 消毒托盤（目錄編號 #3708 和 #3709）K152743M/L-10 CLIP APPLIER STERILIZATION TRAY (商品編號#3706)

相關器械（代碼：GEI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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