FDA Registration
Active
🇺🇸 United States
0220-240-300 L12 LED Light Source with Advanced Imaging Modality
Reg #: 2936485
·
FEI: 2936485
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- STRYKER ENDOSCOPY
- Registration Number
- 2936485
- FEI Number
- 2936485
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5900 Optical Ct
- City
- SAN JOSE
- State
- CA
- ZIP
- 95138
- Country
- US
Regulatory Submissions
- 510(k) Number
- K230754
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscope, Neurological | GWG | Class 2 | Neurology | No | 2023-04-12 |
| Confocal Optical Imaging | OWN | Class 2 | Gastroenterology, Urology | No | 2023-04-12 |
| Light, Catheter, Fiberoptic, Glass, Ureteral | FCS | Class 2 | Gastroenterology, Urology | No | 2023-04-12 |
| Light Source, Fiberoptic, Routine | FCW | Class 2 | Gastroenterology, Urology | No | 2023-04-12 |
Proprietary Names
0220-240-300 L12 LED Light Source with Advanced Imaging Modality
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device