WILSON-COOK BALLOON INFLATION DEVICE— 510(k) K933845
Substantially EquivalentWilson-Cook Medical, Inc.
FDA 510(k) clearance K933845 for WILSON-COOK BALLOON INFLATION DEVICE, Substantially Equivalent on 1994-11-29. Applicant: Wilson-Cook Medical, Inc..
Clearance details
- Applicant
- Wilson-Cook Medical, Inc.
- Product code
- Code KNQ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Lafayette, IN, US
Adverse events under product code KNQ
product code KNQ- Malfunction
- 1,844
- Total
- 1,844
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.