FDA Registration
Active
🇺🇸 United States
Acessa ProVu System
Reg #: 3006330030
·
FEI: 3006330030
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Hologic, Inc.
- Registration Number
- 3006330030
- FEI Number
- 3006330030
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 445 Simarano Drive
- City
- Marlborough
- State
- MA
- ZIP
- 01752
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181124
Owner / Operator
- Firm Name
- HOLOGIC, INC.
- Operator Number
- 9007676
- Address
- 250 Campus Drive, --
- City
- Marlborough
- State
- MA
- Postal Code
- 01752
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coagulator, Laparoscopic, Unipolar (And Accessories) | HFG | Class 2 | Obstetrics/Gynecology | No | 2021-11-12 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2021-11-12 |
| Tracking, Soft Tissue, Intraoperative | OEW | Class 2 | Neurology | No | 2021-11-12 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2021-11-12 |
Proprietary Names
Acessa ProVu System
Establishment Types
Manufacture Medical Device