510(k) K080779 ยท FQH Lavage, Jet
IRRISEPT WOUND CLEANSING SYSTEM
| Applicant | Irrimax Corporation, Alpharetta GA, US |
| Decision | Substantially Equivalent, Feb 4, 2009 |
| Received | Mar 19, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080779
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 16, 2019 | IrriMAX Corporation Irrisept Wound Debridement and Cleansing System. 12 units per case. Terminated |
FQH | None listed |
| Sep 5, 2017 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Irrisept OR, Finished Bottle Assembly 450 ml STEP 1 Terminated |
FQH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.