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)

一次性內視鏡注射針

K 號:K232442 · 2023-11-09

決定日期2023-11-09
產品代碼FBK
諮詢委員會GU
決定相當於

器材摘要

Disposable Endoscope Injection Needles is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Soudon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-09 under 510(k) number K232442. 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 Endoscope Injection Needles?

Disposable Endoscope Injection Needles is a medical device that received FDA 510(k) clearance on 2023-11-09. The listed applicant is Zhejiang Soudon Medical Technology Co., Ltd.. The 510(k) number is K232442.

When did Disposable Endoscope Injection Needles receive FDA 510(k) clearance?

Disposable Endoscope Injection Needles received FDA 510(k) clearance on 2023-11-09, under 510(k) number K232442.

Who is the listed applicant for Disposable Endoscope Injection Needles?

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

What is the FDA product code for Disposable Endoscope Injection Needles?

The FDA product code for Disposable Endoscope 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。

其他以 Zhejiang Soudon 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。

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。

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。

↑