Veloxion System
FDA 510(k) clearance K230205 · decided 2023-02-24
Clearance details
- K-number
- K230205
- Device name
- Veloxion System
- Applicant
- Corinth Medtech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-01-25
- Decision date
- 2023-02-24
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- FJL
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.