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510(k) K240552

Irrisept Antimicrobial Wound Lavage by Irrimax Corporation — Product Code FRO

K240552 is an FDA 510(k) premarket notification submitted by Irrimax Corporation for the device "Irrisept Antimicrobial Wound Lavage". The FDA issued a decision of Substantially Equivalent on June 18, 2024. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Irrimax Corporation has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2024
Date Received
February 28, 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 Irrimax Corporation

  • K222804 — Irrisept Antimicrobial Wound Lavage (September 22, 2022)
  • K210536 — Irrisept Antimicrobial Wound Lavage (May 28, 2021)
  • K202222 — Irrisept Wound Debridement and Cleansing System (December 14, 2020)
  • K080779 — IRRISEPT WOUND CLEANSING SYSTEM (February 4, 2009)

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