T4 Fine wire electrode
T4 Fine wire electrode is a Class II device made by Bonart Co., Ltd., cleared under FDA 510(k) K020080 on 19 Feb 2002 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 04719873120499), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04719873120499 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK020080 | Date19 Feb 2002 | StatusActive |
Official records
- AccessGUDID record 04719873120499
- FDA 510(k) database K020080
Across registries
- FDA 510(k) K020080 decided 19 Feb 2002 Active
- FDA GUDID UDI-DI 04719873120499 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K020080
- Listed FDA GUDID 04719873120499
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Electrosurgical system
- Model / reference
- T4
- Primary DI / UDI-DI
- 04719873120499
- 510(k) Number
- FDA product code
- EKZ
- GMDN term
- Electrosurgical system
- Device class
- Class II
- Regulation number
- 872.4920
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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