Cleared Special

K241809 - coactiv+™ Antimicrobial Wound Gel (FDA 510(k) Clearance)

K241809 · Kane Biotech, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
28d
Days
-
Risk

K241809 is an FDA 510(k) clearance for the coactiv+™ Antimicrobial Wound Gel. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Kane Biotech, Inc. (Winnipeg, CA). The FDA issued a Cleared decision on July 19, 2024 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Kane Biotech, Inc. devices

Submission Details

510(k) Number K241809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2024
Decision Date July 19, 2024
Days to Decision 28 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 114d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Acostar Limited
Valerie Acosta

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRO Dressing, Wound, Drug

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