FDA Registration
Active
🇺🇸 United States
KARL STORZ IMAGING, INC.
Reg #: 2027009
·
FEI: 2027009
·
Expires 2026
Products
16
Proprietary Names
34
Establishment Types
2
Classifications
16
Registration Details
- Registration Name
- KARL STORZ IMAGING, INC.
- Registration Number
- 2027009
- FEI Number
- 2027009
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1 S Los Carneros Rd
- City
- Goleta
- State
- CA
- ZIP
- 93117
- Country
- US
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 |
|---|---|---|---|---|---|
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2020-08-12 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2015-11-25 |
| Endoscope, Neurological | GWG | Class 2 | Neurology | No | 2017-03-17 |
| Confocal Optical Imaging | OWN | Class 2 | Gastroenterology, Urology | No | 2017-03-06 |
| Camera, Cine, Endoscopic, With Audio | FTS | Class 1 | General, Plastic Surgery | No | 2013-04-11 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2013-12-26 |
| Camera, Television, Endoscopic, Without Audio | FWF | Class 1 | General, Plastic Surgery | No | 2007-11-14 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2008-11-25 |
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | Class 2 | Ophthalmic | No | 2007-11-21 |
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2007-11-21 |
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | Class 1 | Gastroenterology, Urology | No | 2019-03-15 |
| Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use | PYO | Class 1 | General Hospital | No | 2022-06-07 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2015-11-25 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2017-03-06 |
| Light Source System, Diagnostic Endoscopic | OAY | Class 3 | Unknown | No | 2010-09-16 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2013-04-11 |
Proprietary Names
C-Cam
TIPCAM 1S 3D System
KARL STORZ ICG Imaging System
GI CCU
KARL STORZ Endoscopic ICG Imaging System
Camera
Flexible Video-Uretero-Renoscope
Flex-XC
H1 Camera Head
Laproscopy Insstruments
LAPAROCAM
KARL STORZ ICG System
NEO
NEO IP
Camera, ophthalmic, ac-powered
12G-SDI CABLE,
KARL STORZ Image1 S Camera Control Unit
Endoscope Accessories
Tape and bandage, adhesive, adjustable closing mechanism, OTC use
Ureteroscope and accessories, flexible/rigid
ENDOSCOPE ACCESSORIES
Laproscopy
SPIES 3D System
Endoscope Accessory
Image 1 SPIES
SSU Flexible Video-Uretero-Renoscope
Light source system, diagnostic endoscopic
Image1 S CCU, Image1 S 4U camera head
KARL STORZ ENDOVISION HYSTEROCAM
KARL STORZ ENDOVISION UROCAM
KARL STORZ HYSTEROCAM
IMAGE1
Image Processing System
Device Imaging Storage
Establishment Types
Manufacture Device in the United States for Export Only
Manufacture Medical Device for Another Party (Contract Manufacturer)