# K063195: Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034 and LF5044

- Pathway: 510(k) (Traditional)
- Applicant: Valleylab
- Decided: Nov 29, 2006 after 40 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). 12 ancestors in all.
31 later devices descend from it; 5 cite it directly.
0 of 44 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.
- K043273: Ligasure Vessel Sealing System. Ligasure Instruments, Valleylab (2005) Summary page 1.
- K904560: Valleylab Laparoscopic Handswitch/Electrodes, Valleylab, Inc. (1990) Summary page 1.
- K964175: Valleylab E2750 Laparoscopic Handset, Valleylab E2770 Series Electrodes, Valleylab, Inc. (1996) Summary page 1.

## Most influential descendants
- K081129: Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, Etrio-314D,-325D,-335D,-345D, Enseal Universal (2008), 24 descendants of its own
- K111202: Surgical Tissue Management System (2012), 11 descendants of its own
- K101990: Ethicon Endo-Surgery Generator G11, Model GEN11 (2011), 11 descendants of its own
- K141122: Harmonic Scallop Blade, Generator G11 (2014), 9 descendants of its own
- K132703: Thunderbeat (2014), 9 descendants of its own

## Indications for use
The Valleylab LigaSure AdvanceTM is a 5mm laparoscopic, electrosurgical instrument that incorporates both monopolar and LigaSureTM tissue fusion (bipolar) functionality. It is intended for use with the Valleylab ForceTriadEM energy platform (electrosurgical generator) in general and gynecological, laparoscopic, surgical procedures where ligation and division of vessels, including lymph vessels, is desired. The monopolar feature of the instrument will be used where electrical dissection through tissue planes and creation of cnterotomies or gastrotomies is desired. Indications for use include general and gynecological, laparoscopic surgical procedures (including urologic, vascular, thoracic and thoracoscopic) where electrosurgical ligation and division of vessels, including lymph vessels, is performed. These procedures include: laparoscopic gastric bypass, laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, laparoscopic colectomy, adhesiolysis, oophorectomy, etc. The Valleylab LigaSure AdvanceTM 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. The Valleylab LigaSure AdvanceTM has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

Source page: https://510kreport.com/device/K063195
Methodology: https://510kreport.com/methodology