Irrisept Antimicrobial Wound Lavage (K240552) - FDA 510(k) Clearance

K240552 is an FDA 510(k) clearance for the Irrisept Antimicrobial Wound Lavage. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Irrimax Corporation (Lawrenceville, US). The FDA issued a Cleared decision on June 18, 2024 after a review of 111 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Irrimax Corporation devices