510(k) K800608— STONE DISLODGER
Substantially EquivalentG.D. Searle and Co.
Clearance details
- Applicant
- G.D. Searle and Co.
- Product code
- Code FFL
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, 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.