FDA Registration
Active
🇺🇸 United States
Electrodes
Reg #: 3026612481
·
FEI: 3026612481
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Covidien
- Registration Number
- 3026612481
- FEI Number
- 3026612481
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 200 Medtronic Drive
- City
- Lafayette
- State
- CO
- ZIP
- 80026
- Country
- US
Regulatory Submissions
- 510(k) Number
- K813071
Owner / Operator
- Firm Name
- Covidien llc
- Operator Number
- 1282497
- Address
- 15 HAMPSHIRE STREET, --
- City
- Mansfield
- State
- MA
- Postal Code
- 02048
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2007-11-30 |
Proprietary Names
Electrodes
Valleylab Rocker Switch Pencil, E2515, E2515NSB, and E2515GNSB
Valleylab Button Switch Pencil Needle Electrode, Holster, E2516HDA
Valleylab Rocker Switch Pencil Needle Electrode, Holster, E2515HDA and E2515HDANSB
Valleylab Rocker Switch Pencil Holster, E2515H, E2515HDB, E2515HDBNSB, E2515HGNSB, and E2515HNSB
Valleylab Button Switch Pencil, E2516, E2516GNSB, and E2516NSB
Valleylab Button Switch Pencil Holster, E2516H, E2516HGNSB, and E2516HNSB
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility