LigaSure 8
by Covidien LP
LigaSure 8 is a Class II device made by Covidien LP, cleared under FDA 510(k) K981916 on 28 Aug 1998 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10884524002767), 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 | Number10884524002767 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK981916 | Date28 Aug 1998 | StatusActive |
Official records
- AccessGUDID record 10884524002767
- FDA 510(k) database K981916
Across registries
- FDA 510(k) K981916 decided 28 Aug 1998 Active
- FDA GUDID UDI-DI 10884524002767 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K981916
- Listed FDA GUDID 10884524002767
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- LigaSure
- Generic name
- Electrosurgical system generator
- Model / reference
- LigaSure 8
- Primary DI / UDI-DI
- 10884524002767
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Electrosurgical system generator
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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