Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
FDA 510(k) clearance K191335 · decided 2019-06-06
Clearance details
- K-number
- K191335
- Device name
- Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
- Applicant
- Corinth Medtech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-05-17
- Decision date
- 2019-06-06
- Days to decision
- 20 days
- Clearance type
- Special
- Product code
- HIH
- Device class
- 2
- Regulation number
- 884.1690
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- 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.