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510(k) K190129

AC5 Topical Gel by Arch Therapeutics, Inc. — Product Code FRO

K190129 is an FDA 510(k) premarket notification submitted by Arch Therapeutics, Inc. for the device "AC5 Topical Gel". The FDA issued a decision of Substantially Equivalent on Mar 11, 2020. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Arch Therapeutics, Inc. has 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 11, 2020
Date Received
Jan 28, 2019
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 Arch Therapeutics, Inc.

  • K182681 — AC5 Topical Gel (Dec 14, 2018)

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