FDA 510(k)

斯泰里卡普安全針；維特雷克安全針

K 號：K233343 · 2023-11-27

決定日期2023-11-27

產品代碼FMI

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

SteriCap Safety Needle; VitreJect Safety Needle is the device name listed in this FDA 510(k) record. The listed applicant is Ocuject, LLC. It received FDA 510(k) clearance on 2023-11-27 under 510(k) number K233343. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SteriCap Safety Needle; VitreJect Safety Needle?

SteriCap Safety Needle; VitreJect Safety Needle is a medical device that received FDA 510(k) clearance on 2023-11-27. The listed applicant is Ocuject, LLC. The 510(k) number is K233343.

When did SteriCap Safety Needle; VitreJect Safety Needle receive FDA 510(k) clearance?

SteriCap Safety Needle; VitreJect Safety Needle received FDA 510(k) clearance on 2023-11-27, under 510(k) number K233343.

Who is the listed applicant for SteriCap Safety Needle; VitreJect Safety Needle?

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

What is the FDA product code for SteriCap Safety Needle; VitreJect Safety Needle?

The FDA product code for SteriCap Safety Needle; VitreJect Safety Needle is FMI.

其他以 Ocuject, LLC 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。

K242956LDS針；OcuSafe® LDS針；SteriCap® LDS安全針；VitreJect® LDS安全針 K230959VitreJect®針頭；OcuSafe®針頭 K230372維特賈克針筒 K212544迷你載量針筒 K212805醫療設備名稱：SteriCap Mini針頭和標準針頭 K202432迷你載量針筒

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相關器械（代碼：FMI）

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。

K261266MOWANA™ 自動雙用式醫療設備PENTAMASTER MEDIQ SDN BHD K261719Promisemed X-Safety 靜脈針Promisemed Hangzhou Meditech Co., Ltd.K262427針筒針（普通型I類，安全型IIA，安全型IIB，安全型IIIA，安全型IIIB，安全型IV，安全型V，普通型VIA，普通型VIB，普通型VIC，安全型VII，普通型IB，安全型VIII，安全型IX，安全型X，普通型XI，安全型XII）Hh Global Technology, Inc.K260933安全性無菌皮下針筒（NR-S1816R、NR-S1916R、NR-S1925R、NR-S1938R、NR-S2016R、NR-S2025R、NR-S2038R、NR-S2051R、NR-S2116R、NR-S2125R、NR-S2138R、NR-S2151R、NR-S2216R、NR-S2225R、NR-S2238R、NR-S2251R、NR-S2316R、NR-S2325R、NR-S2338R、NR-S2351R、NR-S2516R、NR-S2525R、NR-S2538R、NR-S2551R、NR-S2516T、NR-S2525T、NR-S2538T、NR-S2551T）Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™雙安全針筒CMT Health PTE., Ltd.K260739Profoject™ 靜脈針（型號A；型號B）CMT Health PTE., Ltd.

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