FDA 510(k)

Sorbact 黏膜敷料-繩狀紗布

K 號：K171225 · 2017-08-21

決定日期2017-08-21

產品代碼FRO

決定相當於

器材摘要

Sorbact Wound Dressing-Ribbon Gauze is the device name listed in this FDA 510(k) record. The listed applicant is Abigo Medical AB. It received FDA 510(k) clearance on 2017-08-21 under 510(k) number K171225. 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 Sorbact Wound Dressing-Ribbon Gauze?

Sorbact Wound Dressing-Ribbon Gauze is a medical device that received FDA 510(k) clearance on 2017-08-21. The listed applicant is Abigo Medical AB. The 510(k) number is K171225.

When did Sorbact Wound Dressing-Ribbon Gauze receive FDA 510(k) clearance?

Sorbact Wound Dressing-Ribbon Gauze received FDA 510(k) clearance on 2017-08-21, under 510(k) number K171225.

Who is the listed applicant for Sorbact Wound Dressing-Ribbon Gauze?

The FDA 510(k) record lists Abigo Medical AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sorbact Wound Dressing-Ribbon Gauze?

The FDA product code for Sorbact Wound Dressing-Ribbon Gauze is FRO. This falls under the Anesthesiology category.

其他以 Abigo Medical AB 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。

K153674Sorbact 泡沫柔邊，Sorbact 超強吸水

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 GmbH K254041皮膚智選抗菌濕凝膠Magic Science Supply, LLC K261646Redermax® 抗菌傷口組織Beijing Kreate Medical Co., Ltd.K253665Vashe Plus 抗菌溶液Urgo Medical North America, LLC K251929SilverCeuticals® 抗菌傷口膠Silverceuticals, Inc.K261023微達辛傷口灌洗溶液Sonoma Pharmaceuticals, Inc.

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。