Peralta Stone Removal Catheter— 510(k) K190492
Substantially EquivalentCalcula Technologies, Inc.
FDA 510(k) clearance K190492 for Peralta Stone Removal Catheter, Substantially Equivalent on 2019-07-18. Applicant: Calcula Technologies, Inc..
Clearance details
- Applicant
- Calcula Technologies, Inc.
- Product code
- Code FFL
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Francisco, CA, 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.