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510(k) K182680

KerraContact Ag Perf Advanced Perforated Silver Wound Dressing by Exciton Technologies, Inc. — Product Code FRO

K182680 is an FDA 510(k) premarket notification submitted by Exciton Technologies, Inc. for the device "KerraContact Ag Perf Advanced Perforated Silver Wound Dressing". The FDA issued a decision of Substantially Equivalent on Dec 6, 2018. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Exciton Technologies, Inc. has 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 6, 2018
Date Received
Sep 26, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Review Panel
SU
Submission Type
510(k)

Other clearances by Exciton Technologies, Inc.

  • K162508 — KerraCel Ag Gelling Fiber Silver Dressing (Feb 13, 2017)
  • K133775 — EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING (Mar 26, 2014)
  • K113564 — EXSALT T7 WOUND DRESSING (Dec 15, 2011)
  • K103067 — EXSALT SD7 WOUND DRESSING (May 20, 2011)
  • K100580 — EXSALT WOUND DRESSING (Oct 12, 2010)
  • K083870 — EXSALT SD7 WOUND DRESSING (Jul 30, 2009)

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