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510(k) K252759

revyve® Antimicrobial Skin and Wound Cleanser by Kane Biotech, Inc. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2026
Date Received
August 29, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Kane Biotech, Inc.

  • K241809 — coactiv+™ Antimicrobial Wound Gel (July 19, 2024)
  • K223259 — coactiv+™ Antimicrobial Wound Gel (May 24, 2023)

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  • K250890 — SBC1 Cream (January 12, 2026)
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  • K250642 — LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) (November 19, 2025)
  • K250115 — Hemastyl(™) Wound Dressing (October 14, 2025)
  • K251866 — Tegaderm Post-Op Transparent Antimicrobial Dressing (October 10, 2025)