FDA 510(k)

allFlex 腎管導管，Krait 腎管導管

K 號：K220730 · 2022-10-13

決定日期2022-10-13

產品代碼KOD

諮詢委員會GU

決定相當於

器材摘要

allFlex Ureteral Catheters, Krait Ureteral Catheters 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 2022-10-13 under 510(k) number K220730. 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 allFlex Ureteral Catheters, Krait Ureteral Catheters?

allFlex Ureteral Catheters, Krait Ureteral Catheters is a medical device that received FDA 510(k) clearance on 2022-10-13. The listed applicant is Allwin Medical Devices, Inc.. The 510(k) number is K220730.

When did allFlex Ureteral Catheters, Krait Ureteral Catheters receive FDA 510(k) clearance?

allFlex Ureteral Catheters, Krait Ureteral Catheters received FDA 510(k) clearance on 2022-10-13, under 510(k) number K220730.

Who is the listed applicant for allFlex Ureteral Catheters, Krait Ureteral Catheters?

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 allFlex Ureteral Catheters, Krait Ureteral Catheters?

The FDA product code for allFlex Ureteral Catheters, Krait Ureteral Catheters is KOD.

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。

K220781ARMADA 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 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）

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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.K220036Wellead 腎管導尿管Well Lead Medical Co., Ltd.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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