FDA 510(k)

單次使用无菌皮下注射針筒（20ml、30ml、50ml、60ml）

K 號：K252279 · 2026-04-17

決定日期2026-04-17

產品代碼FMF

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

Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) is the device name listed in this FDA 510(k) record. The listed applicant is Chirana T.Injecta,A.S.. It received FDA 510(k) clearance on 2026-04-17 under 510(k) number K252279. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)?

Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) is a medical device that received FDA 510(k) clearance on 2026-04-17. The listed applicant is Chirana T.Injecta,A.S.. The 510(k) number is K252279.

When did Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) receive FDA 510(k) clearance?

Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) received FDA 510(k) clearance on 2026-04-17, under 510(k) number K252279.

Who is the listed applicant for Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)?

The FDA 510(k) record lists Chirana T.Injecta,A.S. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)?

The FDA product code for Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) is FMF.

其他以 Chirana T.Injecta,A.S. 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。

K252483腸內針筒（20ml, 60ml）

相關器械（代碼：FMF）

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。

K262581GraftGun 適用性移植輸送系統 (GDS®)SurGenTec, LLC K252184SOL-M 輪狀釋放針筒配可交換針盤Sol-Millennium Medical, Inc.K253747一次性針筒注射器（KXYC-03C02，KXYC-03A03）Jiangsu Enjosim Medical Technology Co., Ltd.K260208超細™ 安全胰島素針embecta Medical II, LLC K253110溶滑安全針；溶滑安全針搭配針筒Sol-Millennium Medical, Inc.K260514Profoject™ 安全針；Profoject™ 配有安全針的注射器；Profoject™ 低死腔配有安全針的注射器CMT Health PTE., Ltd.

官方來源

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