Valleylab SEP6000
by Covidien LP
Valleylab SEP6000 is a Class II device made by Covidien LP, cleared under FDA 510(k) K182772 on 19 Nov 2018 and listed in FDA GUDID since 11 Jan 2019 (UDI-DI 10884521750913), 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 | Number10884521750913 | Date11 Jan 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182772 | Date19 Nov 2018 | StatusActive |
Official records
- AccessGUDID record 10884521750913
- FDA 510(k) database K182772
Across registries
- FDA 510(k) K182772 decided 19 Nov 2018 Active
- FDA GUDID UDI-DI 10884521750913 listed 11 Jan 2019 Listed
Timeline
- Cleared FDA 510(k) K182772
- Listed FDA GUDID 10884521750913
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Valleylab
- Generic name
- Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
- Model / reference
- SEP6000
- Primary DI / UDI-DI
- 10884521750913
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 3 Meter
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