FDA 510(k)

ClearEVAC 腎管吸引進入鞘 (PUS-100-1040, PUS-100-1050, PUS-100-1240, PUS-100-1250)

K 號：K260521 · 2026-04-06

申請人Zhuhai Pusen Medical Technology Co., Ltd.

決定日期2026-04-06

產品代碼FED

諮詢委員會GU

決定相當於

器材摘要

ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) is the device name listed in this FDA 510(k) record. The listed applicant is Zhuhai Pusen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-06 under 510(k) number K260521. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)?

ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) is a medical device that received FDA 510(k) clearance on 2026-04-06. The listed applicant is Zhuhai Pusen Medical Technology Co., Ltd.. The 510(k) number is K260521.

When did ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) receive FDA 510(k) clearance?

ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) received FDA 510(k) clearance on 2026-04-06, under 510(k) number K260521.

Who is the listed applicant for ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)?

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

What is the FDA product code for ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)?

The FDA product code for ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) is FED.

其他以 Zhuhai Pusen Medical Technology Co., Ltd. 為申請人之記錄

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相關器械（代碼：FED）

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

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