Data / Medical devices / United States / Irrimax Corporation
Irrimax Corporation: FDA-registered device maker in Lawrenceville, GA, United States, 3 510(k) clearances
Irrimax Corporation is registered with the FDA (registration 3005706359) in Lawrenceville, GA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 18, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005706359
- Address
- 1665 Lakes Parkway Suite 102, Lawrenceville, GA, United States, 30043
- Owner or operator
- IRRIMAX CORPORATION (9086561)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- August 25, 2022
- Registered through
- 2026
- Brand names listed
- Irrisept Antimicrobial Wound Lavage, Irrisept Antimicrobial Wound Lavage, Accessories Kit, Irrisept Antimicrobial Wound Lavage, Wound Solution Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Lavage, Jet | FQH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 18, 2024 | K240552 | Irrisept Antimicrobial Wound Lavage | FRO | Substantially Equivalent | Irrimax Corporation | accessdata.fda.gov |
| September 22, 2022 | K222804 | Irrisept Antimicrobial Wound Lavage | FQH | Substantially Equivalent | Irrimax Corporation | accessdata.fda.gov |
| May 28, 2021 | K210536 | Irrisept Antimicrobial Wound Lavage | FQH | Substantially Equivalent | Irrimax Corporation | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 16, 2019 | 83599 | Class II | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
Updated June 18, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.