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510(k) K180570

Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) by Argentum Medical, LLC — Product Code FRO

K180570 is an FDA 510(k) premarket notification submitted by Argentum Medical, LLC for the device "Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)". The FDA issued a decision of Substantially Equivalent on January 14, 2019. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Argentum Medical, LLC has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2019
Date Received
March 5, 2018
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 Argentum Medical, LLC

  • K241225 — Silverlon® Wound Contact, Burn Contact Dressing (July 31, 2024)
  • K221218 — Silverlon Wound Contact, Burn Contact Dressings (October 26, 2022)
  • K190343 — Silverlon Wound Contact, Burn Contact Dressings (July 18, 2019)
  • K150256 — SILVERLON BURN CONTACT DRESSINGS (April 30, 2015)
  • K143001 — SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING (November 7, 2014)
  • K141033 — SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EAS (September 12, 2014)
  • K141573 — SILVERLON ISLAND WOUND DRESSING (August 28, 2014)
  • K122817 — SILVERLON ISLAND WOUND DRESSING (May 1, 2014)
  • K053590 — SILVERLON CA (CALCIUM ALGINATE) (October 6, 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