510(k) K230205— Veloxion System
Substantially EquivalentCorinth Medtech, Inc.
Clearance details
- Applicant
- Corinth Medtech, Inc.
- Product code
- Code FJL
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Jose, CA, US
Adverse events under product code FJL
product code FJL- Death
- 2
- Total
- 2
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.