FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Irrisept Antimicrobial Wound Lavage
K Number: K240552
·
Decision Jun 18, 2024
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
5
Review Days
111
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
- K240552
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Irrimax Corporation
- Date Received
- February 28, 2024
- Decision Date
- June 18, 2024
- Product Code
- FRO
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FRO), ordered by most recent decision date.
Bonvadis®
FDA 510(k)
FDA Unclassified
·Unknown
StatSeal Disc
FDA 510(k)
FDA Unclassified
·Unknown
IWD-Gel
FDA 510(k)
FDA Unclassified
·Unknown
MiraChlor Antimicrobial Wound Solution
FDA 510(k)
FDA Unclassified
·Unknown
Promogran Prisma Collagen Matrix with ORC and Silver
FDA 510(k)
FDA Unclassified
·Unknown
LUOFUCON® Antimicrobial Wound Gel
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Irrimax Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K222804 | Irrisept Antimicrobial Wound Lavage | Sep 22, 2022 | 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 |