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510(k) K213473

Antimicrobial Gelling Fiber Dressing with PHMB by Advanced Medical Solutions, Ltd. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2023
Date Received
October 28, 2021
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 Advanced Medical Solutions, Ltd.

  • K210974 — High Performance Antimicrobial Gelling Fiber with Silver (May 12, 2021)
  • K190819 — Silicone PHMB Foam Wound Dressing (July 25, 2019)
  • K183645 — Silver High Performance Dressing (May 29, 2019)
  • K180634 — Surgical Silver Post Operative Dressing (August 7, 2018)
  • K181197 — PHMB Foam Wound Dressing (August 3, 2018)
  • K163062 — PHMB Antimicrobial Foam Wound Dressing (July 25, 2017)
  • K032742 — SILVER FOAM WOUND DRESSING (August 16, 2004)
  • K041316 — ANTIMICROBIAL ALGINATE DRESSING (August 5, 2004)
  • K024298 — ANTIMICROBIAL ALGINATE DRESSING (June 30, 2003)
  • K010245 — ACTIVHEAL SCAR MANAGEMENT DRESSING (April 25, 2001)

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  • K251582 — Redermax Antibacterial Wound Matrix (February 2, 2026)
  • K252568 — New Day Skin Spray (January 23, 2026)
  • K250890 — SBC1 Cream (January 12, 2026)
  • K252759 — revyve® Antimicrobial Skin and Wound Cleanser (January 8, 2026)
  • K251757 — Puracyn® Plus Antimicrobial Irrigation Solution (January 5, 2026)
  • K252167 — Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber (December 19, 2025)
  • K250642 — LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) (November 19, 2025)
  • K250115 — Hemastyl(™) Wound Dressing (October 14, 2025)