FDA Registration
Active
🇺🇸 United States
Saberscope
Reg #: 3013445147
·
FEI: 3013445147
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- XENOCOR
- Registration Number
- 3013445147
- FEI Number
- 3013445147
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 615 Arapeen Drive, Suite # 205
- City
- Salt Lake City
- State
- UT
- ZIP
- 84108
- Country
- US
Regulatory Submissions
- 510(k) Number
- K193315
Owner / Operator
- Firm Name
- Xenocor
- Operator Number
- 10053582
- Address
- 615 Arapeen Drive, Suite # 205
- City
- Salt Lake City
- State
- UT
- Postal Code
- 84108
- Country
- US
- Correspondent
- Tony Watson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2020-02-06 |
| Endoscope, Flexible | GCQ | Class 2 | Gastroenterology, Urology | No | 2020-02-06 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2020-02-06 |
Proprietary Names
Saberscope
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198