Ureterorenoscope System— 510(k) K201293
Substantially EquivalentShanghai AnQing Medical Instrument Co., Ltd.
FDA 510(k) clearance K201293 for Ureterorenoscope System, Substantially Equivalent on 2020-07-24. Applicant: Shanghai AnQing Medical Instrument Co., Ltd..
Clearance details
- Applicant
- Shanghai AnQing Medical Instrument Co., Ltd.
- Product code
- Code FGB
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Shanghai, CN
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.