GREEN CROSS URINARY DRAINAGE BAG— 510(k) K843117
Substantially EquivalentTech-Cons Ltd., Intl.
FDA 510(k) clearance K843117 for GREEN CROSS URINARY DRAINAGE BAG, Substantially Equivalent on 1984-10-11. Applicant: Tech-Cons Ltd., Intl..
Clearance details
- Applicant
- Tech-Cons Ltd., Intl.
- Product code
- Code KNX
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
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.