FDA 510(k)

Wellead 腎管導尿管

K 號：K220036 · 2022-12-16

決定日期2022-12-16

產品代碼KOD

諮詢委員會GU

決定相當於

器材摘要

Wellead Ureteral Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-12-16 under 510(k) number K220036. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Wellead Ureteral Catheter?

Wellead Ureteral Catheter is a medical device that received FDA 510(k) clearance on 2022-12-16. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K220036.

When did Wellead Ureteral Catheter receive FDA 510(k) clearance?

Wellead Ureteral Catheter received FDA 510(k) clearance on 2022-12-16, under 510(k) number K220036.

Who is the listed applicant for Wellead Ureteral Catheter?

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

What is the FDA product code for Wellead Ureteral Catheter?

The FDA product code for Wellead Ureteral Catheter is KOD.

其他以 Well Lead Medical Co., Ltd. 為申請人之記錄

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K241734Wellead® 水性間歇性導尿管預先使用型；Wellead® 水性間歇性導尿管簡易型 K220722PVC親水性尿道導尿管 K211543魏鼻噴管 K211814Wellead內視鏡密封圈 K202134全導引矽膠福樸導尿管，配備溫度感測器 K203119ClearPetra 吸排式套管

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相關器械（代碼：KOD）

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。

K251864橡膠多功能導尿管C.R. Bard, Inc.K220730allFlex 腎管導管，Krait 腎管導管Allwin Medical Devices, Inc.K211032尿道導尿管 12 Fr，尿道導尿管 16 FrUrogen Pharma, Ltd.K181979魯士 FloCath Quick 18 Fr. 弯曲性親水性間歇性導尿管Teleflexmedical, Inc.K180354UroGen 腎盂導尿管Urogen Pharma, Ltd.K181144角形尖端輸尿管導管Cook Incorporated

官方來源

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