免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter

K 號：K220781 · 2023-05-05

申請人Allwin Medical Devices, Inc.
決定日期2023-05-05
產品代碼EZN
諮詢委員會GU
決定相當於

器材摘要

ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Allwin Medical Devices, Inc.. It received FDA 510(k) clearance on 2023-05-05 under 510(k) number K220781. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter?

ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter is a medical device that received FDA 510(k) clearance on 2023-05-05. The listed applicant is Allwin Medical Devices, Inc.. The 510(k) number is K220781.

When did ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter receive FDA 510(k) clearance?

ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter received FDA 510(k) clearance on 2023-05-05, under 510(k) number K220781.

Who is the listed applicant for ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter?

The FDA 510(k) record lists Allwin Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter?

The FDA product code for ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter is EZN.

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

其他以 Allwin Medical Devices, Inc. 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。

K220730allFlex 腎管導管，Krait 腎管導管K203626SureStrip 經濟凍結針，SureLock 經濟凍結針K200248Allwin胚胎移植針（ETC），Allwin ETC針芯和柔軟塞子K190659腎盂管支架開放尖端/閉合尖端/手術中尖端，經腎盂鏡腎盂管支架開放尖端/閉合尖端，兒童腎盂管支架開放尖端/閉合尖端，單J型尿分流腎盂管支架開放尖端/閉合尖端，多環腎盂管支架開放尖端/閉合尖端K190590Allwin卵子拾取針（ACE單腔卵子拾取針，OVUMPICK雙腔卵子拾取針，ACE-FL單腔卵子拾取針帶灌洗管，ACE-M手動單腔卵子拾取針）K190522Allwin宮腔內注射針（INSEMINA和INSEMINA開口尖宮腔內注射針，CURVED和CURVED開口尖宮腔內注射針，TRACKABLE和TRACKABLE開口尖宮腔內注射針，FLEXI和FLEXI開口尖宮腔內注射針，STUMPY宮腔內注射針）

查看所有 7 項裝置 →

相關器械（代碼：EZN）

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。

K250910Optilume® 高壓泌尿學氣球擴張導尿管Urotronic, Inc.K201007In-Ka 腎管氣球擴張針管Coloplast Corp.K190612EQUINOX 气球擴張導管Dornier Medtech America, Inc.K173654輸尿管擴張器組合，輸尿管擴張器Cook IncorporatedK180756安全導絲導管Cook IncorporatedK180028Cook 810 設備組，Desilets-Hoffman 引導器組Cook Incorporated

官方來源

在 FDA 資料庫中查看 →

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。

↑