FDA 510(k)

一次性內視鏡閥門系統

K 號：K221331 · 2022-09-08

申請人Changzhou Endoclean Medical Device Co., Ltd.

決定日期2022-09-08

產品代碼ODC

諮詢委員會GU

決定相當於

器材摘要

Disposable Endoscope Valves System is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Endoclean Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2022-09-08 under 510(k) number K221331. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Endoscope Valves System?

Disposable Endoscope Valves System is a medical device that received FDA 510(k) clearance on 2022-09-08. The listed applicant is Changzhou Endoclean Medical Device Co., Ltd.. The 510(k) number is K221331.

When did Disposable Endoscope Valves System receive FDA 510(k) clearance?

Disposable Endoscope Valves System received FDA 510(k) clearance on 2022-09-08, under 510(k) number K221331.

Who is the listed applicant for Disposable Endoscope Valves System?

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

What is the FDA product code for Disposable Endoscope Valves System?

The FDA product code for Disposable Endoscope Valves System is ODC.

其他以 Changzhou Endoclean Medical Device Co., Ltd. 為申請人之記錄

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相關器械（代碼：ODC）

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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