FDA 510(k)

coactiv+™ 抗菌傷口膠

K 號：K241809 · 2024-07-19

決定日期2024-07-19

產品代碼FRO

決定相當於

器材摘要

coactiv+™ Antimicrobial Wound Gel is the device name listed in this FDA 510(k) record. The listed applicant is Kane Biotech, Inc.. It received FDA 510(k) clearance on 2024-07-19 under 510(k) number K241809. 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 coactiv+™ Antimicrobial Wound Gel?

coactiv+™ Antimicrobial Wound Gel is a medical device that received FDA 510(k) clearance on 2024-07-19. The listed applicant is Kane Biotech, Inc.. The 510(k) number is K241809.

When did coactiv+™ Antimicrobial Wound Gel receive FDA 510(k) clearance?

coactiv+™ Antimicrobial Wound Gel received FDA 510(k) clearance on 2024-07-19, under 510(k) number K241809.

Who is the listed applicant for coactiv+™ Antimicrobial Wound Gel?

The FDA 510(k) record lists Kane Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for coactiv+™ Antimicrobial Wound Gel?

The FDA product code for coactiv+™ Antimicrobial Wound Gel is FRO. This falls under the Anesthesiology category.

其他以 Kane Biotech, Inc. 為申請人之記錄

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K252759revyve® 抗菌皮膚及傷口清潔劑 K223259coactiv+™ 抗菌傷口膠

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。

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官方來源

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