FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Irrisept Antimicrobial Wound Lavage
K Number: K222804
·
Decision Sep 22, 2022
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
52
Applicant Total
5
Review Days
6
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Irrisept Antimicrobial Wound Lavage
- K Number
- K222804
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5475
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Irrimax Corporation
- Date Received
- September 16, 2022
- Decision Date
- September 22, 2022
- Product Code
- FQH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FQH | Lavage, Jet | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FQH), ordered by most recent decision date.
BD Surgiphor Antimicrobial Irrigation System (910110)
FDA 510(k)
FDA Class 2
·General Hospital
BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120)
FDA 510(k)
FDA Class 2
·General Hospital
ERBEJET® 2 System
FDA 510(k)
FDA Class 2
·General Hospital
Armis VeriCyn Wound Wash
FDA 510(k)
FDA Class 2
·General Hospital
VERSAJET Hydrosurgery System (III)
FDA 510(k)
FDA Class 2
·General Hospital
BD Surgiphor Antimicrobial Irrigation System
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Irrimax Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K240552 | Irrisept Antimicrobial Wound Lavage | Jun 18, 2024 | Substantially Equivalent |
| K210536 | Irrisept Antimicrobial Wound Lavage | May 28, 2021 | Substantially Equivalent |
| K202222 | Irrisept Wound Debridement and Cleansing System | Dec 14, 2020 | Substantially Equivalent |
| K080779 | IRRISEPT WOUND CLEANSING SYSTEM | Feb 4, 2009 | Substantially Equivalent |