Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF— 510(k) K183188
Substantially EquivalentRichard Wolf Medical Instruments Corporation
FDA 510(k) clearance K183188 for Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF, Substantially Equivalent on 2019-05-03. Applicant: Richard Wolf Medical Instruments Corporation.
Clearance details
- Applicant
- Richard Wolf Medical Instruments Corporation
- Product code
- Code FGB
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vernon Hills, IL, US
Adverse events under product code FGB
product code FGB- Death
- 6
- Injury
- 552
- Malfunction
- 3,922
- Other
- 1
- Total
- 4,481
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.