Ligasure Vessel Sealing System Ligasure Instruments
by Valleylab 510(k)
Active
510(k) K043273
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK043273 | Date5 Jan 2005 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Ligasure Vessel Sealing System Ligasure Instruments is a device that provides a combination of pressure and energy to create vessel fusion. It operates by delivering precise energy and electrode pressure to vessels for a controlled time period to achieve complete and permanent fusion of the vessel lumen.
The system is supplied as a reusable instrument system and is used in general and plastic surgery settings. It is not sterile and requires cleaning and sterilization between uses. The device received FDA 510(k) clearance (K043273) on January 5, 2005, and is substantially equivalent to a predicate device.
Other devices from Valleylab, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Ligasure Vessel Sealing System Ligasure Instruments used for?
The Ligasure Vessel Sealing System Ligasure Instruments is used to create permanent fusion of vessel lumens by delivering precise energy and electrode pressure for a controlled time period. It is intended for use in general and plastic surgery settings where vessel sealing is required during procedures.
Is the Ligasure Vessel Sealing System Ligasure Instruments sterile when supplied?
No, the Ligasure Vessel Sealing System Ligasure Instruments is not sterile when supplied. It is a reusable instrument system that must be cleaned and sterilized between uses according to the manufacturer's instructions to ensure safe reuse in surgical environments.
How is the Ligasure Vessel Sealing System Ligasure Instruments supplied and maintained?
The Ligasure Vessel Sealing System Ligasure Instruments is supplied as a reusable instrument system. It is not sterile and requires thorough cleaning and sterilization between each use to maintain functionality and prevent cross-contamination. Proper maintenance is essential for safe and effective reuse in surgical settings.