# K043273: Ligasure Vessel Sealing System. Ligasure Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Valleylab
- Decided: Jan 5, 2005 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: 2 generations back to K932293 (1994). 7 ancestors in all.
37 later devices descend from it; 5 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981916: Ligasure Vessel Sealing System, Valleylab, Inc. (1998) Summary page 1.

## Most influential descendants
- K063195: Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034 and LF5044 (2006), 31 descendants of its own
- 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

## Indications for use
The LigaSure TM Vessel Sealing System includes a bipolar electrosurgical generator and dedicated bipolar electrosurgical instruments intended for use in general, laparoscopic and gynecologic surgical procedures where ligation of vessels, including lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coagulation) to vessels interposed between the jaws of the device. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired. The indications for use include general (including urologic, thoracic, plastic and reconstructive), laparoscopic, and gynecological procedures where ligation of vessels is performed, including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholesystectomies, laparoscopically assisted vaginal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomy, etc. The devices can be used on vessels up to 7mm and bundles as large as will fit in the jaws of the instruments. The LigaSureTM Vessel Sealing System 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/K043273
Methodology: https://510kreport.com/methodology