Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch
FDA 510(k) clearance K190099 · decided 2019-03-15
Clearance details
- K-number
- K190099
- Device name
- Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch
- Applicant
- Corinth Medtech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-01-22
- Decision date
- 2019-03-15
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- FJL
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Cupertino, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.