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510(k) K100580

EXSALT WOUND DRESSING by Exciton Technologies, Inc. — Product Code FRO

K100580 is an FDA 510(k) premarket notification submitted by Exciton Technologies, Inc. for the device "EXSALT WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on Oct 12, 2010. 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
Oct 12, 2010
Date Received
Mar 2, 2010
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)
  • 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)
  • 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