FDA 510(k)

內視鏡灌洗管

K 號：K230773 · 2023-11-21

申請人Zhejiang Chuangxiang Medical Technology Co., Ltd.

決定日期2023-11-21

產品代碼OCX

諮詢委員會GU

決定相當於

器材摘要

Endoscopy Irrigation Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K230773. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Endoscopy Irrigation Tubing?

Endoscopy Irrigation Tubing is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. The 510(k) number is K230773.

When did Endoscopy Irrigation Tubing receive FDA 510(k) clearance?

Endoscopy Irrigation Tubing received FDA 510(k) clearance on 2023-11-21, under 510(k) number K230773.

Who is the listed applicant for Endoscopy Irrigation Tubing?

FDA 510(k) 記錄將浙江創想醫療技術有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Endoscopy Irrigation Tubing?

The FDA product code for Endoscopy Irrigation Tubing is OCX.

其他以 Zhejiang Chuangxiang 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。

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相關器械（代碼：OCX）

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。

K251986輔助水管 MAJ-855Olympus Medical Systems Corporation K251997單次使用病理切片閥 (MAJ-1555)Olympus Medical Systems Corporation K242586ArgoCap (200.52)Ovesco Endoscopy AG K241704內視鏡式水泵Hangzhou AGS MedTech Co., Ltd.K242357水壺（MAJ-901）；水壺（MAJ-902）Olympus Medical Systems Corporation K241874吸引針 (2189)Hobbs Medical, Inc.

官方來源

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