Irrisept Antimicrobial Wound Lavage— 510(k) K222804

Name: FDA 510(k) clearance K222804
Creator: U.S. Food and Drug Administration
Published: 2022-09-22

Substantially Equivalent

Irrimax Corporation

FDA 510(k) clearance K222804 for Irrisept Antimicrobial Wound Lavage, Substantially Equivalent on 2022-09-22. Applicant: Irrimax Corporation. Device class: 2.

Clearance details

Applicant: Irrimax Corporation
Product code: Code FQH
Device class: Class 2
Regulation: 21 CFR 880.5475
Advisory panel: General Hospital
Date received: 2022-09-16
Decision date: 2022-09-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Lawrenceville, GA, US

Download summary PDF View on FDA.gov ↗

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K220759 — Armis VeriCyn Wound Wash2023-05-25
K220964 — VERSAJET Hydrosurgery System (III)2023-05-16

More clearances from Irrimax Corporation

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K240552 — Irrisept Antimicrobial Wound Lavage2024-06-18
K210536 — Irrisept Antimicrobial Wound Lavage2021-05-28
K202222 — Irrisept Wound Debridement and Cleansing System2020-12-14
K080779 — IRRISEPT WOUND CLEANSING SYSTEM2009-02-04

Adverse events under product code FQH

product code FQH

Injury: 170
Malfunction: 2,513
Other: 1
Total: 2,684

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.