FDA 510(k)

Allwin胚胎移植針（ETC），Allwin ETC針芯和柔軟塞子

K 號：K200248 · 2020-07-01

決定日期2020-07-01

產品代碼MQF

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators 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 2020-07-01 under 510(k) number K200248. The device is classified under product code MQF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators?

Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators is a medical device that received FDA 510(k) clearance on 2020-07-01. The listed applicant is Allwin Medical Devices, Inc.. The 510(k) number is K200248.

When did Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators receive FDA 510(k) clearance?

Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators received FDA 510(k) clearance on 2020-07-01, under 510(k) number K200248.

Who is the listed applicant for Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators?

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 Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators?

The FDA product code for Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators is MQF.

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 K220730allFlex 腎管導管，Krait 腎管導管 K203626SureStrip 經濟凍結針，SureLock 經濟凍結針 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：MQF）

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。

K253354Minitro胚胎移植針管（ETCA23175、ETCA23175-C、ETCB20175、ETCB20175-C、ETCB20175-ET、ETCB20175-ET-C）Guangzhou Hehong Biotech Co., Ltd.K243373胚胎移植針管組合：EmbryoCath 胚胎移植針管 - 預曲 230 mm (參考編號 17500)；EmbryoCath 胚胎移植針管 - 直型可塑 180 mm (參考編號 17501)；EmbryoCath 胚胎移植針管 - 直型可塑 230 mm (參考編號 17502)；EmbryoCath 射針 - 180 mm (參考編號 17510)；EmbryoCath 射針 - 230 mm (參考編號 17511)Vitrolife Sweden AB K240307VitaVitro 胚胎移植針管（型號 ET-S、ET-SI、ET-A、ET-I、ET-IH）Shenzhen Vitavitro Biotech Co., Ltd.K231730FemaSeed 鼓室內射精器Femasys, Inc.K220010百合單次使用无菌胚胎移植針管Shanghai Horizon Medical Technology Co., Ltd.K192540北澤田ET心导管Kitazato Corporation

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。