Irrimax Corporation
Medical device manufacturer in Lawrenceville, GA.
5510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K240552 | Irrisept Antimicrobial Wound LavageFRO · Traditional | 06/18/2024SE |
| K222804 | Irrisept Antimicrobial Wound LavageFQH · Special | 09/22/2022SE |
| K210536 | Irrisept Antimicrobial Wound LavageFQH · Traditional | 05/28/2021SE |
| K202222 | Irrisept Wound Debridement and Cleansing SystemFQH · Traditional | 12/14/2020SE |
| K080779 | Irrisept Wound Cleansing SystemFQH · Traditional | 02/04/2009SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0191-2020 Class II | Irrisept Wound Debridement and Cleansing System. 12 units per case.Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance. | 08/16/2019Terminated |