FDA 510(k)

ProSeal™ 內袋釘針配附加孔 (423370ST, 423370)

K 號：K251340 · 2025-05-29

決定日期2025-05-29

產品代碼ONB

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

ProSeal™ Bag Spike with Additive Port (423370ST, 423370) is the device name listed in this FDA 510(k) record. The listed applicant is Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2025-05-29 under 510(k) number K251340. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ProSeal™ Bag Spike with Additive Port (423370ST, 423370)?

ProSeal™ Bag Spike with Additive Port (423370ST, 423370) is a medical device that received FDA 510(k) clearance on 2025-05-29. The listed applicant is Epic Medical Pte. , Ltd.. The 510(k) number is K251340.

When did ProSeal™ Bag Spike with Additive Port (423370ST, 423370) receive FDA 510(k) clearance?

ProSeal™ Bag Spike with Additive Port (423370ST, 423370) received FDA 510(k) clearance on 2025-05-29, under 510(k) number K251340.

Who is the listed applicant for ProSeal™ Bag Spike with Additive Port (423370ST, 423370)?

The FDA 510(k) record lists Epic Medical Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProSeal™ Bag Spike with Additive Port (423370ST, 423370)?

The FDA product code for ProSeal™ Bag Spike with Additive Port (423370ST, 423370) is ONB.

其他以 Epic Medical Pte. , Ltd. 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。

K252987ADRx® 混合設備 K250234SMARTeZ™ 輕量化膠質輸液泵（RS系列）K251722ProSeal™ 轉移注射器（421120、421130、421140）K251814EZ™ 靜脈注射輸液套組 K252094eZSURE™ 空液體容器 K243976ZeroClear™ 袋裝取用器（423100）

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相關器械（代碼：ONB）

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。

K251722ProSeal™ 轉移注射器（421120、421130、421140）Epic Medical Pte. , Ltd.K253033Chemfort® 28天 20mm 藥瓶適配器及 13mm 轉換器Simplivia Healthcare , Ltd.K250059BD PhaSeal™ Optima 連接組 (C83-O)；BD PhaSeal™ Optima 尖嘴組 (C180-O)Becton, Dickinson and Company K251411Chemfort 女性路氏釘釋針適配器Simplivia Healthcare , Ltd.K243976ZeroClear™ 袋裝取用器（423100）Epic Medical Pte. , Ltd.K240517ProSeal™ 開放式通用安瓿瓶適配器Epic Medical Pte. , Ltd.

官方來源

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