FDA 510(k)

魯士軟簡塑福樸利氧導管

K 號：K252537 · 2026-01-20

決定日期2026-01-20

產品代碼EZL

諮詢委員會GU

決定相當於

器材摘要

Rusch SoftSimplastic Foley Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical Sdn. Bhd.. It received FDA 510(k) clearance on 2026-01-20 under 510(k) number K252537. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Rusch SoftSimplastic Foley Catheters?

Rusch SoftSimplastic Foley Catheters is a medical device that received FDA 510(k) clearance on 2026-01-20. The listed applicant is Teleflex Medical Sdn. Bhd.. The 510(k) number is K252537.

When did Rusch SoftSimplastic Foley Catheters receive FDA 510(k) clearance?

Rusch SoftSimplastic Foley Catheters received FDA 510(k) clearance on 2026-01-20, under 510(k) number K252537.

Who is the listed applicant for Rusch SoftSimplastic Foley Catheters?

FDA 510(k) 記錄將Teleflex Medical Sdn. Bhd. 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 Rusch SoftSimplastic Foley Catheters?

The FDA product code for Rusch SoftSimplastic Foley Catheters is EZL.

其他以 Teleflex Medical Sdn. Bhd. 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。

K262056魯士拉特克斯金福樓伊姆導尿管 K252643Iso-Gard過濾直管；濕氣通風過濾器小型斜角

相關器械（代碼：EZL）

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。

K260756TraumaGuard 腹腔內壓力感知系統 (000-0221)Sentinel Medical Technologies,K262056魯士拉特克斯金福樓伊姆導尿管Teleflex Medical Sdn. Bhd.K243011矽膠尿道導尿管（矽膠尿道導尿管）Guangdong Ecan Medical Co., Ltd.K241424InnoCare 專業福爾伊灌腸器Innocare Urologics, LLC K232469魯施天然乳膠金屬福樸導尿管Teleflexmedical, Inc.K240057傷害守護內腹腔壓力感知系統Sentinel Medical Technologies, LLC

官方來源

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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。