FDA Registration
Active
🇺🇸 United States
TENEX HEALTH
Reg #: 3009750704
·
FEI: 1000135560
·
Expires 2026
Products
1
Proprietary Names
15
Establishment Types
2
Classifications
1
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Registration Details
- Registration Name
- TENEX HEALTH
- Registration Number
- 3009750704
- FEI Number
- 1000135560
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 26902 Vista Terrace
- City
- Lake Forest
- State
- CA
- ZIP
- 92630
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153299
Owner / Operator
- Firm Name
- Tenex Health
- Operator Number
- 10042896
- Address
- 26902 Vista Terrace
- City
- Lake Forest
- State
- CA
- Postal Code
- 92630
- Country
- US
- Correspondent
- David Vancelette
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2024-12-03 |
Proprietary Names
Tenex 2nd Generation Microtip
TX2 Procedure Pack
TX Supply Kit
TX System Console
TX2 MicroTip
Tenex Health TX System
TX1 Tissue Removal System
TX1 Procedure Pack
TX1 MicroTip
TX-Bone
TXB MicroTip
TXP Procedure Pack
TXP MicroTip
TXB Procedure Pack
TX-DFU Procedure Pack
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device