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510(k) K223310

Antimicrobial Silicone PHMB Foam Wound Dressing by Advanced Medical Solutions Limited — Product Code FRO

K223310 is an FDA 510(k) premarket notification submitted by Advanced Medical Solutions Limited for the device "Antimicrobial Silicone PHMB Foam Wound Dressing". The FDA issued a decision of Substantially Equivalent on April 5, 2023. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Advanced Medical Solutions Limited has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2023
Date Received
October 28, 2022
Clearance Type
Special
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 Limited

  • K211878 — LiquiBand XL (May 23, 2022)
  • K183570 — LiquiBand Plus (March 9, 2020)
  • K110458 — SILVER ANTIMICROBIAL WOUND GEL (March 14, 2011)
  • K091013 — SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND (July 30, 2009)
  • K090453 — SILVER ALGINATE 11 WOUND DRESSING (February 26, 2009)
  • K080503 — SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING (November 12, 2008)
  • K081363 — NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBI (September 24, 2008)
  • K073197 — SILVER ANTIMICROBIAL WOUND GEL (August 28, 2008)
  • K070581 — SILVER ALGINATE II WOUND DRESSING (July 13, 2007)
  • K063173 — MODIFICATION TO SILVER ALGINATE II WOUND DRESSING (November 3, 2006)

Other clearances for product code FRO

  • 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)
  • K252028 — LUOFUCON® Antimicrobial Wound Gel (March 11, 2026)
  • K251582 — Redermax Antibacterial Wound Matrix (February 2, 2026)
  • K252568 — New Day Skin Spray (January 23, 2026)

FDA data resources