# K031011: Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500

- Pathway: 510(k) (Traditional)
- Applicant: Valleylab, Inc.
- Decided: May 29, 2003 after 59 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K932293 (1994). 8 ancestors in all.
114 later devices descend from it; 9 cite it directly.
0 of 123 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.
- K010013: Ligasure Laparoscopic Sealer Divider Model LS1100, Valleylab, Inc. (2001) Summary page 1.

## Most influential descendants
- K092879: Ligasure 5MM Blunt Tip Laparoscopic Sealer-Divider (2009), 65 descendants of its own
- K102470: Lugasure Curved, Small Jaw, Open Sealer/Divider (2011), 64 descendants of its own
- K113572: Ligasure Curved, Small Jaw, Open Sealer/Divider (2012), 62 descendants of its own
- K133338: Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX) (2013), 43 descendants of its own
- K130744: Ligasure 5MM Blunt Tip Laparoscopic Sealer/Divider (2013), 42 descendants of its own

## Recalls of this device
- Nov 4, 2011 · Not classified · Z-0640-2012: Retaining pins in handle assembly may disengage and fall into surgical field or compromise handle unlatching.
- Nov 4, 2011 · Not classified · Z-0641-2012: Retaining pins in handle assembly may disengage and fall into surgical field or compromise handle unlatching.

## Indications for use
The LigaSureTM5mm 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 application of RF electrosurgical energy to vascular structures (vessels) interposed between the jaws of the instrument. A blade within the instrument is surgeon- actuated to divide tissue. Indications for use include general laparoscopic 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 LigaSure 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. The LigaSure 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/K031011
Methodology: https://510kreport.com/methodology