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510(k) K171191

Hexagen Derm by Global Health Solutions, LLC — Product Code FRO

K171191 is an FDA 510(k) premarket notification submitted by Global Health Solutions, LLC for the device "Hexagen Derm". The FDA issued a decision of Substantially Equivalent on Aug 25, 2017. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Global Health Solutions, LLC has 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 25, 2017
Date Received
Apr 24, 2017
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 Global Health Solutions, LLC

  • K160872 — PolyPlex Wound Dressing (Nov 23, 2016)

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