Cleared Traditional

revyve? Antimicrobial Skin and Wound Cleanser

K252759 · Kane Biotech, Inc. · General & Plastic Surgery
Jan 2026
Decision
132d
Days
Risk

About This 510(k) Submission

K252759 is an FDA 510(k) clearance for the revyve? Antimicrobial Skin and Wound Cleanser, a Dressing, Wound, Drug, submitted by Kane Biotech, Inc. (Winnipeg, CA). The FDA issued a Cleared decision on January 8, 2026, 132 days after receiving the submission on August 29, 2025. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K252759 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2025
Decision Date January 08, 2026
Days to Decision 132 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FRO — Dressing, Wound, Drug
Device Class

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