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FDA 510(k)

超銀色膠凝纖維敷料

K 號：K221720 · 2022-12-21

申請人Winner Medical Co., Ltd.
決定日期2022-12-21
產品代碼FRO
決定相當於

器材摘要

Extra Silver Gelling Fiber Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Winner Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-12-21 under 510(k) number K221720. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Extra Silver Gelling Fiber Dressing?

Extra Silver Gelling Fiber Dressing is a medical device that received FDA 510(k) clearance on 2022-12-21. The listed applicant is Winner Medical Co., Ltd.. The 510(k) number is K221720.

When did Extra Silver Gelling Fiber Dressing receive FDA 510(k) clearance?

Extra Silver Gelling Fiber Dressing received FDA 510(k) clearance on 2022-12-21, under 510(k) number K221720.

Who is the listed applicant for Extra Silver Gelling Fiber Dressing?

The FDA 510(k) record lists Winner Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Extra Silver Gelling Fiber Dressing?

The FDA product code for Extra Silver Gelling Fiber Dressing is FRO. This falls under the Anesthesiology category.

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 Winner Medical Co., Ltd. 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。

K252001膠原蛋白傷口敷料K250082程序口罩/外科口罩/臉部口罩K231057抗菌膠膠布傷口敷料K231564皮膚與傷口清潔劑K231152膠原蛋白傷口敷料K221311抗菌繃帶

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相關器械（代碼：FRO）

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。

K254168Actolind® (06.3637. Actolind®膠漿)ACTO GmbHK254041皮膚智選抗菌濕凝膠Magic Science Supply, LLCK261646Redermax® 抗菌傷口組織Beijing Kreate Medical Co., Ltd.K253665Vashe Plus 抗菌溶液Urgo Medical North America, LLCK251929SilverCeuticals® 抗菌傷口膠Silverceuticals, Inc.K261023微達辛傷口灌洗溶液Sonoma Pharmaceuticals, Inc.

官方來源

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