Irrisept Antimicrobial Wound Lavage— 510(k) K210536

Substantially Equivalent

Irrimax Corporation

FDA 510(k) clearance K210536 for Irrisept Antimicrobial Wound Lavage, Substantially Equivalent on 2021-05-28. Applicant: Irrimax Corporation.

Clearance details

Applicant: Irrimax Corporation
Product code: Code FQH
Advisory panel: General Hospital
Date received: 2021-02-24
Decision date: 2021-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lawrenceville, GA, US

Download summary PDF View on FDA.gov ↗

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.