FDA Registration
Active
🇺🇸 United States
Echotip® Open-End Ureteral Catheter
Reg #: 1825146
·
FEI: 1825146
·
Expires 2025
Products
1
Proprietary Names
14
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Cook Incorporated
- Registration Number
- 1825146
- FEI Number
- 1825146
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1100 W Morgan St
- City
- Spencer
- State
- IN
- ZIP
- 47460
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171662
Owner / Operator
- Firm Name
- COOK, INC.
- Operator Number
- 1820334
- Address
- 750 DANIELS WAY
- City
- Bloomington
- State
- IN
- Postal Code
- 47404
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2018-05-10 |
Proprietary Names
Echotip® Open-End Ureteral Catheter
Whistle Tip Ureteral Catheter (Left)
Spiral Tip Ureteral Access Catheter
Open-End Flexi-Tip® Ureteral Catheter
Open-End Ureteral Catheter
Flexi-Tip® Ureteral Catheter (Left)
Flexi-Tip® Ureteral Catheter (Right)
Round Tip Ureteral Catheter (Left)
Pediatric Ureteral Catheter
Open-End Beveled Flexi-Tip® Ureteral Catheter
Open-End Ureteral Catheter Sof-Flex®
Round Tip Ureteral Catheter (Right)
Whistle Tip Ureteral Catheter (Right)
Whistle Tip Ureteral Catheter
Establishment Types
Manufacture Medical Device