一次性內視鏡注射針
K 號：K252021 · 2025-12-02
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器材摘要
Disposable Endoscopic Injection Needles is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou New Med Micro-Medtech Co., Ltd.. It received FDA 510(k) clearance on 2025-12-02 under 510(k) number K252021. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Disposable Endoscopic Injection Needles?
Disposable Endoscopic Injection Needles is a medical device that received FDA 510(k) clearance on 2025-12-02. The listed applicant is Changzhou New Med Micro-Medtech Co., Ltd.. The 510(k) number is K252021.
When did Disposable Endoscopic Injection Needles receive FDA 510(k) clearance?
Disposable Endoscopic Injection Needles received FDA 510(k) clearance on 2025-12-02, under 510(k) number K252021.
Who is the listed applicant for Disposable Endoscopic Injection Needles?
The FDA 510(k) record lists Changzhou New Med Micro-Medtech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Disposable Endoscopic Injection Needles?
The FDA product code for Disposable Endoscopic Injection Needles is FBK.
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。
相關器械（代碼：FBK）
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。
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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。
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