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FDA 510(k)

RetroPerc柔軟輸尿管鏡導引逆行腎造口針刺套件

K 號：K160077 · 2016-07-12

申請人Jbw7 Innovations, LLC
決定日期2016-07-12
產品代碼LJE
決定相當於

器材摘要

RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set is the device name listed in this FDA 510(k) record. The listed applicant is Jbw7 Innovations, LLC. It received FDA 510(k) clearance on 2016-07-12 under 510(k) number K160077. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

常見問題

What is the RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set?

RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set is a medical device that received FDA 510(k) clearance on 2016-07-12. The listed applicant is Jbw7 Innovations, LLC. The 510(k) number is K160077.

When did RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set receive FDA 510(k) clearance?

RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set received FDA 510(k) clearance on 2016-07-12, under 510(k) number K160077.

Who is the listed applicant for RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set?

The FDA 510(k) record lists Jbw7 Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set?

The FDA product code for RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set is LJE.

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：LJE）

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。

K250448一次性經皮腎盂穿刺擴張套件Shenzhen Trious Medical Technology Co., Ltd.K222705導入針Youcare Technology Co.,Ltd. (Wuhan)K211911Kolibri 皮膚穿刺腎盂造口管，Kolibri 皮膚穿刺腎盂造口套件，Kolibri 直接穿刺套件Coloplast Corp.K201165In-Ka 皮膚穿刺球囊擴張針，Ampatz 套管Coloplast Corp.K191498庫克-科普迴路腎盂造口套件，超膠劑腎盂造口套件配麥洛克，超膠劑會陰造口套件配麥洛克Cook IncorporatedK190903羅森逆行性腎盂造口針刺套件Cook Incorporated

官方來源

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