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510(k) K162508

KerraCel Ag Gelling Fiber Silver Dressing by Exciton Technologies, Inc. — Product Code FRO

K162508 is an FDA 510(k) premarket notification submitted by Exciton Technologies, Inc. for the device "KerraCel Ag Gelling Fiber Silver Dressing". The FDA issued a decision of Substantially Equivalent on Feb 13, 2017. 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
Feb 13, 2017
Date Received
Sep 8, 2016
Clearance Type
Traditional
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.

  • K182680 — KerraContact Ag Perf Advanced Perforated Silver Wound Dressing (Dec 6, 2018)
  • 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