Cleared Traditional

K223259 - coactiv+™ Antimicrobial Wound Gel (FDA 510(k) Clearance)

K223259 · Kane Biotech, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
212d
Days
-
Risk

K223259 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 May 24, 2023 after a review of 212 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Kane Biotech, Inc. devices

Submission Details

510(k) Number K223259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2022
Decision Date May 24, 2023
Days to Decision 212 days
Submission Type Traditional
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
98d slower than avg
Panel avg: 114d · This submission: 212d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Albert Rego, PhD, Inc.
Albert Rego

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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