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FDA 510(k)

RocaTub 腎管導尿管

K 號：K192183 · 2020-04-23

申請人Promepal Sam
決定日期2020-04-23
產品代碼EYB
諮詢委員會GU
決定相當於

器材摘要

RocaTub Ureteral Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Promepal Sam. It received FDA 510(k) clearance on 2020-04-23 under 510(k) number K192183. The device is classified under product code EYB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RocaTub Ureteral Catheter?

RocaTub Ureteral Catheter is a medical device that received FDA 510(k) clearance on 2020-04-23. The listed applicant is Promepal Sam. The 510(k) number is K192183.

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

RocaTub Ureteral Catheter received FDA 510(k) clearance on 2020-04-23, under 510(k) number K192183.

Who is the listed applicant for RocaTub Ureteral Catheter?

The FDA 510(k) record lists Promepal Sam as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RocaTub Ureteral Catheter?

The FDA product code for RocaTub Ureteral Catheter is EYB.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：EYB）

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。

K191187多尼爾 MINNOW 腎管導管Dornier Medtech America, Inc.K183323UPJ 遏流氣球導管Cook IncorporatedK182695尾管輸尿管導管套件，Sof-Flex AQ 遮蔽尾管輸尿管導管Cook IncorporatedK182122腎盂輸尿管導管Coloplast Corp.K180182雙腔輸尿管進入導管，Flexi-Tip雙腔輸尿管進入導管Cook IncorporatedK171043輸尿管導尿管，清潔輸尿管導尿管，柔軟尖端防水處理輸尿管導尿管Coloplast Corp.

官方來源

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