FDA Registration
Active
🇺🇸 United States
Total Performance System - Hermes
Reg #: 2936485
·
FEI: 2936485
·
Expires 2025
Products
6
Proprietary Names
2
Establishment Types
1
Classifications
6
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
- K991696
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 |
|---|---|---|---|---|---|
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2009-04-29 |
| Unit, Operative Dental | EIA | Class 1 | Dental | No | 2009-04-29 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2009-04-29 |
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2009-04-29 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2009-04-29 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2009-04-29 |
Proprietary Names
Total Performance System - Hermes
TPS FOOTSWITCH PACKAGE
Establishment Types
Manufacture Medical Device