FDA Registration
Active
🇺🇸 United States
NEPTUNE MEDICAL, INC
Reg #: 3015451828
·
FEI: 3015451828
·
Expires 2026
Products
4
Proprietary Names
6
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- NEPTUNE MEDICAL, INC
- Registration Number
- 3015451828
- FEI Number
- 3015451828
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1828 El Camino Real, 5th Floor
- City
- Burlingame
- State
- CA
- ZIP
- 94010
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240853
Owner / Operator
- Firm Name
- Neptune Medical, Inc
- Operator Number
- 10061389
- Address
- 1828 El Camino Real, Suite 508
- City
- Burlingame
- State
- CA
- Postal Code
- 94010
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2024-07-03 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2024-07-03 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2021-05-26 |
| Colonoscope And Accessories, Flexible/Rigid | FDF | Class 2 | Gastroenterology, Urology | No | 2021-05-26 |
Proprietary Names
Pathfinder CR System
Tape Cut Guide
Pathfinder SB
Pathfinder Endoscope Overtube
Pathfinder
Pathfinder Endoscope Cap
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device