FDA Registration
Active
🇺🇸 United States
SDC3 Device Control Package
Reg #: 2936485
·
FEI: 2936485
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
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
- K201434
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 |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2021-05-04 |
Proprietary Names
SDC3 Device Control Package
Connected OR HUB Device Control Package
CONNECTED OR HUB VIP PACKAGE
Connected OR Hub Device Control
Connected OR Hub Voice Control
Establishment Types
Manufacture Medical Device