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FDA 510(k)

coactiv+™ Antimicrobial Wound Gel

K-Number: K241809 · 2024-07-19

ApplicantKane Biotech, Inc.
Decision Date2024-07-19
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Kane Biotech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252759revyve® Antimicrobial Skin and Wound CleanserK223259coactiv+™ Antimicrobial Wound Gel

Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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