FDA Registration
Active
🇺🇸 United States
SpyGlass DS Digital Controller
Reg #: 3003018722
·
FEI: 3003018722
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ENERCON TECHNOLOGIES
- Registration Number
- 3003018722
- FEI Number
- 3003018722
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 25 NORTHBROOK DR., P.O. BOX 665
- City
- GRAY
- State
- ME
- ZIP
- 04039
- Country
- US
Regulatory Submissions
- 510(k) Number
- K142922
Owner / Operator
- Firm Name
- ENERCON TECHNOLOGIES
- Operator Number
- 9051058
- Address
- 25 NORTHBROOK DR., P.O. BOX 665
- City
- Gray
- State
- ME
- Postal Code
- 04039
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Choledochoscope And Accessories, Flexible/Rigid | FBN | Class 2 | Gastroenterology, Urology | No | 2015-02-02 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2015-02-02 |
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2015-02-02 |
Proprietary Names
SpyGlass DS Digital Controller
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)