510(k) K003580— UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER
Substantially EquivalentUnisensor AG
Clearance details
- Applicant
- Unisensor AG
- Product code
- Code FFX
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Golden, CO, US
Adverse events under product code FFX
product code FFX- Other
- 1
- Total
- 1
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.