免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

單次使用无菌針筒針；單次使用无菌針筒針- 可棄針筒針；單次使用无菌針筒針- 自封針筒針

K 號：K232165 · 2024-02-01

申請人Berpu Medical Technology Co., Ltd.
決定日期2024-02-01
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

Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles is the device name listed in this FDA 510(k) record. The listed applicant is Berpu Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-01 under 510(k) number K232165. 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 Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles?

Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles is a medical device that received FDA 510(k) clearance on 2024-02-01. The listed applicant is Berpu Medical Technology Co., Ltd.. The 510(k) number is K232165.

When did Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles receive FDA 510(k) clearance?

Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles received FDA 510(k) clearance on 2024-02-01, under 510(k) number K232165.

Who is the listed applicant for Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles?

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

What is the FDA product code for Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles?

The FDA product code for Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles is FMI.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Berpu Medical Technology Co., 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。

K221045無針胰島素針筒K220061安全胰島素針筒K213158針筒式注射器K213811單次使用无菌皮下注射針筒K212514單次使用安全針筒針，胰島素針筒針K181447單次使用安全胰島素針

查看所有 9 項裝置 →

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 BHDK261719Promisemed 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.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑