510(k) K191335
Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags by
Corinth Medtech, Inc.
— Product Code HIH
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 2019
- Date Received
- May 17, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hysteroscope (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1690
- Review Panel
- OB
- Submission Type