IRRISEPT WOUND CLEANSING SYSTEM— 510(k) K080779
Substantially EquivalentIrrimax Corporation
FDA 510(k) clearance K080779 for IRRISEPT WOUND CLEANSING SYSTEM, Substantially Equivalent on 2009-02-04. Applicant: Irrimax Corporation. Device class: 2.
Clearance details
- Applicant
- Irrimax Corporation
- Product code
- Code FQH
- Device class
- Class 2
- Regulation
- 21 CFR 880.5475
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alpharetta, GA, US
Recent devices under product code FQH
view allMore clearances from Irrimax Corporation
view allAdverse events under product code FQH
product code FQH- Injury
- 170
- Malfunction
- 2,513
- Other
- 1
- Total
- 2,684
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K080779
K-number listed on FDA's recall record- Z-0191-2020 — Irrisept Wound Debridement and Cleansing System. 12 units per case.
- Z-0490-2019 — Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080779.
Data sourced from openFDA. This site is unofficial and independent of the FDA.