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510(k) K240510

Microdacyn Hydrogel by Sonoma Pharmaceuticals, Inc. — Product Code FRO

K240510 is an FDA 510(k) premarket notification submitted by Sonoma Pharmaceuticals, Inc. for the device "Microdacyn Hydrogel". The FDA issued a decision of Substantially Equivalent on November 8, 2024. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Sonoma Pharmaceuticals, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2024
Date Received
February 22, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Sonoma Pharmaceuticals, Inc.

  • K261023 — Microdacyn Wound Irrigation Solution (June 24, 2026)
  • K233399 — Microdacyn Wound Care Solution (September 13, 2024)
  • K173896 — Microcyn Antimicrobial Hydrogel (April 2, 2018)
  • K171935 — Alevicyn SG Antimicrobial Gel (December 1, 2017)
  • K172622 — Microcyn Antimicrobial Skin and Wound Cleanser (November 21, 2017)
  • K172851 — Microcyn Plus Antimicrobial Wound Care Solution (November 15, 2017)
  • K171727 — Hydrocleanse Antimicrobial Skin and Wound Care Solution (July 26, 2017)

Other clearances for product code FRO

  • K261023 — Microdacyn Wound Irrigation Solution (June 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (June 24, 2026)
  • K261638 — Bonvadis® (June 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (April 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (March 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (March 13, 2026)
  • K252028 — LUOFUCON® Antimicrobial Wound Gel (March 11, 2026)
  • K251582 — Redermax Antibacterial Wound Matrix (February 2, 2026)
  • K252568 — New Day Skin Spray (January 23, 2026)

FDA data resources