DUTHOY STONE BASKET— 510(k) K861469
Substantially EquivalentLake Region Mfg., Inc.
FDA 510(k) clearance K861469 for DUTHOY STONE BASKET, Substantially Equivalent on 1986-05-15. Applicant: Lake Region Mfg., Inc..
Clearance details
- Applicant
- Lake Region Mfg., Inc.
- Product code
- Code FFL
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
Adverse events under product code FFL
product code FFL- Death
- 2
- Injury
- 270
- Malfunction
- 2,711
- Other
- 2
- Total
- 2,985
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.