# K062525: Reprocessed Ligasure Vessel Sealer/Divider

- Pathway: 510(k) (Traditional)
- Applicant: Ascent Healthcare Solutions
- Decided: May 16, 2007 after 261 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K932293 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031011: Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500, Valleylab, Inc. (2003) Summary page 1.

## Indications for use
The Reprocessed 5 mm Vessel Sealer-Divider is a bipolar electrosurgical instrument intended for use with the LigaSure Generator in general and gynecologic laparoscopic surgical procedures where ligation and division of vessels is desired. The instrument creates a seal by the application of RF electrosurgical energy to vascular structures (vessels) interposed between the jaws of the instrument. A blade within the instrument is actuated to divide tissue. Indications for use include general laparoscopic surgical procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic laparoscopic procedures where ligation and division of vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The Reprocessed 5mm Vessel Sealer-Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures. The Reprocessed 5mm Vessel Sealer-Divider can be used on vessels up to and including 7mm diameter, and tissue bundles as large as will fit in the jaws of the instrument.

Source page: https://510kreport.com/device/K062525
Methodology: https://510kreport.com/methodology