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510(k) K210536

Irrisept Antimicrobial Wound Lavage by Irrimax Corporation — Product Code FQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2021
Date Received
February 24, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lavage, Jet
Device Class
Class II
Regulation Number
880.5475
Review Panel
HO
Submission Type

Other clearances by Irrimax Corporation

  • K240552 — Irrisept Antimicrobial Wound Lavage (June 18, 2024)
  • K222804 — Irrisept Antimicrobial Wound Lavage (September 22, 2022)
  • K202222 — Irrisept Wound Debridement and Cleansing System (December 14, 2020)
  • K080779 — IRRISEPT WOUND CLEANSING SYSTEM (February 4, 2009)

Other clearances for product code FQH

  • K253996 — BD Surgiphor™ Antimicrobial Irrigation System (910110) (February 25, 2026)
  • K253445 — BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) (February 20, 2026)
  • K231023 — ERBEJET® 2 System (June 15, 2023)
  • K220759 — Armis VeriCyn Wound Wash (May 25, 2023)
  • K220964 — VERSAJET Hydrosurgery System (III) (May 16, 2023)
  • K221504 — BD Surgiphor™ Antimicrobial Irrigation System (October 14, 2022)
  • K222804 — Irrisept Antimicrobial Wound Lavage (September 22, 2022)
  • K210987 — IRRIGO Wound Wash Jet System (May 31, 2022)
  • K213616 — BD Surgiphor Antimicrobial Irrigation System (March 23, 2022)
  • K202222 — Irrisept Wound Debridement and Cleansing System (December 14, 2020)