FDA 510(k)

coactiv+™ 抗菌伤口凝胶

K号: K223259 · 2023-05-24

决定日期2023-05-24

产品代码FRO

决定实质等同

器械摘要

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 2023-05-24 under 510(k) number K223259. 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.

常见问题

What is the coactiv+™ Antimicrobial Wound Gel?

coactiv+™ Antimicrobial Wound Gel is a medical device that received FDA 510(k) clearance on 2023-05-24. The listed applicant is Kane Biotech, Inc.. The 510(k) number is K223259.

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

coactiv+™ Antimicrobial Wound Gel received FDA 510(k) clearance on 2023-05-24, under 510(k) number K223259.

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.

列明Kane Biotech, Inc.为申报人的其他记录

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K252759revyve® 抗菌皮肤和伤口清洁剂 K241809coactiv+™ 抗菌伤口凝胶

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