FDA 510(k)

PuraDERM膠

K 號：K193085 · 2020-05-11

決定日期2020-05-11

產品代碼FRO

決定相當於

器材摘要

PuraDERM Gel is the device name listed in this FDA 510(k) record. The listed applicant is 3-D Matrix, Inc.. It received FDA 510(k) clearance on 2020-05-11 under 510(k) number K193085. 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 PuraDERM Gel?

PuraDERM Gel is a medical device that received FDA 510(k) clearance on 2020-05-11. The listed applicant is 3-D Matrix, Inc.. The 510(k) number is K193085.

When did PuraDERM Gel receive FDA 510(k) clearance?

PuraDERM Gel received FDA 510(k) clearance on 2020-05-11, under 510(k) number K193085.

Who is the listed applicant for PuraDERM Gel?

FDA 510(k) 記錄將 3-D Matrix, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for PuraDERM Gel?

The FDA product code for PuraDERM Gel is FRO. This falls under the Anesthesiology category.

其他以 3-D Matrix, 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。

K261503PuraStat 胃腸設備 K261504PuraStat-RM K222481PuraStat K213552PuraStat-RM K210211PuraStat-OM K210098PuraStat-GI

查看所有 8 項裝置 →

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。