FDA Registration
Active
🇺🇸 United States
Flexor Vision
Reg #: 1820334
·
FEI: 1820334
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- Cook Incorporated
- Registration Number
- 1820334
- FEI Number
- 1820334
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 750 DANIELS WAY
- City
- Bloomington
- State
- IN
- ZIP
- 47404
- Country
- US
Regulatory Submissions
- 510(k) Number
- K072521
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 |
|---|---|---|---|---|---|
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2012-02-22 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2012-02-22 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2012-02-22 |
| Image, Illumination, Fiberoptic, For Endoscope | FFS | Class 2 | Gastroenterology, Urology | No | 2012-02-22 |
| Kit, Nephroscope | FGA | Class 2 | Gastroenterology, Urology | No | 2012-02-22 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2012-02-22 |
Proprietary Names
Flexor Vision
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device