FDA 510(k)

M/L-10 CLIP APPLIER STERILIZATION TRAY (商品編號#3706)

K 號：K152743 · 2016-02-08

決定日期2016-02-08

產品代碼KCT

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) 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 2016-02-08 under 510(k) number K152743. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)?

M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) is a medical device that received FDA 510(k) clearance on 2016-02-08. The listed applicant is Microline Surgical, Inc.. The 510(k) number is K152743.

When did M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) receive FDA 510(k) clearance?

M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) received FDA 510(k) clearance on 2016-02-08, under 510(k) number K152743.

Who is the listed applicant for M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)?

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 M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)?

The FDA product code for M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) is KCT.

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）K213127ReNew可重用剪刀尖 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）

相關器械（代碼：KCT）

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。

K253988LiteSet 盤子Nobel Biocare AB K261935外科及義肢托盤Dentsply Sirona, Inc.K253187SteriBest® 過濾消毒托盤系統Mastel Surgical K252854SteriTite容器系統搭配MediTray產品Case Medical, Inc.K260726斯特羅曼® ProClean™ 裝籠 (041.800 ; 041.801)Institut Straumann AG K253791PUREVUE™ 快速連接針筒系統托盤；PUREVUE™ 快速連接針筒系統蓋DePuy Mitek, Inc.

官方來源

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