PerFect TCS S6008A
PerFect TCS S6008A is a Class II device made by Coltene/Whaledent Inc., cleared under FDA 510(k) K071632 on 18 Oct 2007 and listed in FDA GUDID since 16 Jun 2016 (UDI-DI D661S6008A0), active as of 22 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 | NumberD661S6008A0 | Date16 Jun 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK071632 | Date18 Oct 2007 | StatusActive |
Official records
- FDA 510(k) database K071632
Across registries
- FDA 510(k) K071632 decided 18 Oct 2007 Active
- FDA GUDID UDI-DI D661S6008A0 listed 16 Jun 2016 Listed
Timeline
- Cleared FDA 510(k) K071632
- Listed FDA GUDID D661S6008A0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PerFect TCS
- Generic name
- Electrosurgical system generator
- Model / reference
- S6008A
- Primary DI / UDI-DI
- D661S6008A0
- 510(k) Number
- FDA product code
- EKZ
- GMDN term
- Electrosurgical system generator
- Device class
- Class II
- Regulation number
- 872.4920
- GUDID distribution status
- In Commercial Distribution
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