FDA Registration
Active
🇺🇸 United States
KARL STORZ Image1 S Camera Control Unit
Reg #: 2027009
·
FEI: 2027009
·
Expires 2025
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- KARL STORZ IMAGING, INC.
- Registration Number
- 2027009
- FEI Number
- 2027009
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1 S Los Carneros Rd
- City
- Goleta
- State
- CA
- ZIP
- 93117
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233333
Owner / Operator
- Firm Name
- KARL STORZ SE & CO KG
- Operator Number
- 8010119
- Address
- Dr.-Karl-Storz-Strasse 34,
- City
- TUTTLINGEN
- State
- Baden-Wurttemberg
- Postal Code
- 78532
- Country
- DE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Confocal Optical Imaging | OWN | Class 2 | Gastroenterology, Urology | No | 2023-12-01 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2023-12-01 |
| Endoscope, Neurological | GWG | Class 2 | Neurology | No | 2023-12-01 |
Proprietary Names
KARL STORZ Image1 S Camera Control Unit
KARL STORZ ICG Imaging System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)