Home / 510(k) Clearances / K182681

510(k) K182681

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

K182681 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 Dec 14, 2018. 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
Dec 14, 2018
Date Received
Sep 26, 2018
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.

  • K190129 — AC5 Topical Gel (Mar 11, 2020)

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