Irrisept Wound Debridement and Cleansing System
FDA 510(k) K202222 · Irrimax Corporation
510(k) numberK202222
Submission
- Device name
- Irrisept Wound Debridement and Cleansing System
- Applicant
- Irrimax Corporation
Lawrenceville, GA, US - Received
- August 6, 2020
- Decision date
- December 14, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FQH – Lavage, Jet
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5475
- Specialty
- General Hospital
Other 510(k)s with product code FQH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253996 | BD Surgiphor Antimicrobial Irrigation System (910110)FQH · Special | Becton, Dickinson and Company (BD) | 02/25/2026SE |
| K253445 | BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120)FQH · Traditional | Bd | 02/20/2026SE |
| K231023 | ERBEJET® 2 SystemFQH · Traditional | Erbe Elektromedizin GmbH | 06/15/2023SE |
| K220759 | Armis VeriCyn Wound WashFQH · Traditional | Armis Biopharma, Inc. | 05/25/2023SE |
| K220964 | VERSAJET Hydrosurgery System (III)FQH · Traditional | Smith & Nephew Medical Limited | 05/16/2023SE |
| K221504 | BD Surgiphor Antimicrobial Irrigation SystemFQH · Traditional | Bd | 10/14/2022SE |
| K222804 | Irrisept Antimicrobial Wound LavageFQH · Special | Irrimax Corporation | 09/22/2022SE |
| K210987 | IRRIGO Wound Wash Jet SystemFQH · Traditional | Inopro, Inc. | 05/31/2022SE |
| K213616 | BD Surgiphor Antimicrobial Irrigation SystemFQH · Traditional | Becton, Dickinson and Company | 03/23/2022SE |
| K210536 | Irrisept Antimicrobial Wound LavageFQH · Traditional | Irrimax Corporation | 05/28/2021SE |
More from Irrimax Corporation
| 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 |
| K080779 | Irrisept Wound Cleansing SystemFQH · Traditional | 02/04/2009SE |
Questions and answers
When was Irrisept Wound Debridement and Cleansing System cleared by the FDA?
Irrisept Wound Debridement and Cleansing System (K202222) received a 510(k) decision of Substantially Equivalent on December 14, 2020, 130 days after the submission was received.
What is the product code of K202222?
The FDA product code is FQH – Lavage, Jet, a Class II (moderate risk) device regulated under 21 CFR 880.5475.