Cleared Traditional

coactiv+™ Antimicrobial Wound Gel (K223259) - 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
97d slower than avg
Panel avg: 115d · 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

All 168
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K223259.
Antibacterial bandage
K221570 · Allmed Medical Products Co., Ltd. · Sep 2023
ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing
K223526 · Smith & Nephew Medical Limited · Aug 2023
Antibacterial Bandage
K221311 · Winner Medical Co., Ltd. · Jun 2023
Antimicrobial Silicone PHMB Foam Wound Dressing
K223310 · Advanced Medical Solutions Limited · Apr 2023
BIASURGE Advanced Surgical Solution
K223377 · Rochal Technologies, LLC · Mar 2023
Sterile Silver Alginate Wound Dressing
K220673 · Qingdao Bright Moon Biomedical Materials Co., Ltd. · Mar 2023