510(k) K082995— SMART DILATOR
Substantially EquivalentSafestitch Medical
Clearance details
- Applicant
- Safestitch Medical
- Product code
- Code KNQ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, 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.