Cleared Traditional

K080779 - IRRISEPT WOUND CLEANSING SYSTEM (FDA 510(k) Clearance)

K080779 · Irrimax Corporation · General & Plastic Surgery device

Feb 2009

Decision

322d

Days

Class 2

Risk

K080779 is an FDA 510(k) clearance for the IRRISEPT WOUND CLEANSING SYSTEM. This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).

Submitted by Irrimax Corporation (Alpharetta, US). The FDA issued a Cleared decision on February 4, 2009, 322 days after receiving the submission on March 19, 2008.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5475.

Submission Details

510(k) Number	K080779 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 19, 2008
Decision Date	February 04, 2009
Days to Decision	322 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF