Cleared Special

coactiv+? Antimicrobial Wound Gel

K241809 · Kane Biotech, Inc. · General & Plastic Surgery

Jul 2024

Decision

28d

Days

—

Risk

About This 510(k) Submission

K241809 is an FDA 510(k) clearance for the coactiv+? Antimicrobial Wound Gel, a Dressing, Wound, Drug, submitted by Kane Biotech, Inc. (Winnipeg, CA). The FDA issued a Cleared decision on July 19, 2024, 28 days after receiving the submission on June 21, 2024. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number	K241809 FDA.gov
FDA Decision	Cleared 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