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510(k) K070581

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

K070581 is an FDA 510(k) premarket notification submitted by Advanced Medical Solutions Limited for the device "SILVER ALGINATE II WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on July 13, 2007. 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
July 13, 2007
Date Received
March 1, 2007
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 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)
  • 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)
  • 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