FDA 510(k)

內視鏡清潔連接管，內視鏡CO2來源管

K 號：K221310 · 2022-10-07

申請人Changzhou Endoclean Medical Device Co., Ltd.

決定日期2022-10-07

產品代碼OCX

諮詢委員會GU

決定相當於

器材摘要

Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing 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 2022-10-07 under 510(k) number K221310. 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 Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing?

Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is Changzhou Endoclean Medical Device Co., Ltd.. The 510(k) number is K221310.

When did Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing receive FDA 510(k) clearance?

Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing received FDA 510(k) clearance on 2022-10-07, under 510(k) number K221310.

Who is the listed applicant for Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing?

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 Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing?

The FDA product code for Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing is OCX.

其他以 Changzhou Endoclean Medical Device 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。

K232244一次性內視鏡閥門系統 K221331一次性內視鏡閥門系統

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

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。