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510(k) K090453

SILVER ALGINATE 11 WOUND DRESSING by Advanced Medical Solutions Limited — Product Code FRO

K090453 is an FDA 510(k) premarket notification submitted by Advanced Medical Solutions Limited for the device "SILVER ALGINATE 11 WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on February 26, 2009. 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
February 26, 2009
Date Received
February 23, 2009
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

  • K223310 — Antimicrobial Silicone PHMB Foam Wound Dressing (April 5, 2023)
  • 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)
  • 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

  • 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