ARGYLE PEDIATRIC URINE COLLECTOR— 510(k) K813479
Substantially EquivalentSherwood Medical Co.
FDA 510(k) clearance K813479 for ARGYLE PEDIATRIC URINE COLLECTOR, Substantially Equivalent on 1982-01-07. Applicant: Sherwood Medical Co.. Device class: 2.
Clearance details
- Applicant
- Sherwood Medical Co.
- Product code
- Code KNX
- Device class
- Class 2
- Regulation
- 21 CFR 876.5250
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Adverse events under product code KNX
product code KNX- Malfunction
- 1,064
- Total
- 1,064
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.