IrriMAX Corporation
FDA Regulatory Profile
IrriMAX Corporation appears in FDA public data with 1 recall, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0191-2020, Class II) was initiated on August 16, 2019. Its most recent 510(k) clearance was granted on June 18, 2024.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0191-2020 | Class II | Irrisept Wound Debridement and Cleansing System. 12 units per case. | August 16, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K240552 | Irrisept Antimicrobial Wound Lavage | June 18, 2024 |
| K222804 | Irrisept Antimicrobial Wound Lavage | September 22, 2022 |
| K210536 | Irrisept Antimicrobial Wound Lavage | May 28, 2021 |
| K202222 | Irrisept Wound Debridement and Cleansing System | December 14, 2020 |
| K080779 | IRRISEPT WOUND CLEANSING SYSTEM | February 4, 2009 |