FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch
K Number: K190099
·
Decision Mar 15, 2019
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
23
Applicant Total
7
Review Days
52
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch
- K Number
- K190099
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Corinth Medtech, Inc.
- Date Received
- January 22, 2019
- Decision Date
- March 15, 2019
- Product Code
- FJL
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FJL | Resectoscope | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FJL), ordered by most recent decision date.
KARL STORZ Monopolar Resectoscopes with HF Cable
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KARL STORZ Bipolar Resectoscopes with HF Cable
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Veloxion System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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)
FDA Class 2
·Gastroenterology, Urology
Veloxion System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AED RESECTOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Corinth Medtech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K230205 | Veloxion System | Feb 24, 2023 | Substantially Equivalent |
| K191341 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags | Jun 13, 2019 | Substantially Equivalent |
| 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 | Jun 6, 2019 | Substantially Equivalent |
| K190113 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags | Apr 24, 2019 | Substantially Equivalent |
| K180752 | Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole | Jul 25, 2018 | Substantially Equivalent |
| K162979 | Veloxion System | Mar 24, 2017 | Substantially Equivalent |