ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM— 510(k) K080845
Substantially EquivalentCardinalhealth
FDA 510(k) clearance K080845 for ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM, Substantially Equivalent on 2008-04-30. Applicant: Cardinalhealth. Device class: 2.
Clearance details
- Applicant
- Cardinalhealth
- Product code
- Code JCX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mcgaw Park, IL, US
Recent devices under product code JCX
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- K230569 — Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ) +1 more
Adverse events under product code JCX
product code JCX- Death
- 11
- Malfunction
- 838
- Other
- 1
- Total
- 850
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.