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510(k) K141573

SILVERLON ISLAND WOUND DRESSING by Argentum Medical — Product Code FRO

K141573 is an FDA 510(k) premarket notification submitted by Argentum Medical for the device "SILVERLON ISLAND WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on Aug 28, 2014. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Argentum Medical has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 28, 2014
Date Received
Jun 12, 2014
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 Argentum Medical

  • K241225 — Silverlon® Wound Contact, Burn Contact Dressing (Jul 31, 2024)
  • K221218 — Silverlon Wound Contact, Burn Contact Dressings (Oct 26, 2022)
  • K190343 — Silverlon Wound Contact, Burn Contact Dressings (Jul 18, 2019)
  • K180570 — Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Sil (Jan 14, 2019)
  • K150256 — SILVERLON BURN CONTACT DRESSINGS (Apr 30, 2015)
  • K143001 — SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING (Nov 7, 2014)
  • K141033 — SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EAS (Sep 12, 2014)
  • K122817 — SILVERLON ISLAND WOUND DRESSING (May 1, 2014)
  • K053590 — SILVERLON CA (CALCIUM ALGINATE) (Oct 6, 2006)

Other clearances for product code FRO

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

FDA data resources