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510(k) K163062

PHMB Antimicrobial Foam Wound Dressing by Advanced Medical Solutions, Ltd. — Product Code FRO

K163062 is an FDA 510(k) premarket notification submitted by Advanced Medical Solutions, Ltd. for the device "PHMB Antimicrobial Foam Wound Dressing". The FDA issued a decision of Substantially Equivalent on July 25, 2017. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Advanced Medical Solutions, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2017
Date Received
November 2, 2016
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.

  • K213473 — Antimicrobial Gelling Fiber Dressing with PHMB (October 26, 2023)
  • 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)
  • 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)

Other clearances for product code FRO

  • K254041 — SkinSmart Antimicrobial HydroGel (September 11, 2026)
  • K261646 — Redermax® Antibacterial Wound Matrix (August 14, 2026)
  • K253665 — Vashe Plus Antimicrobial Solution (August 11, 2026)
  • K261023 — Microdacyn Wound Irrigation Solution (June 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (June 24, 2026)
  • K261638 — Bonvadis® (June 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (April 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (March 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (March 13, 2026)

FDA data resources