# K010013: Ligasure Laparoscopic Sealer Divider Model LS1100

- Pathway: 510(k) (Traditional)
- Applicant: Valleylab, Inc.
- Decided: Mar 26, 2001 after 83 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
No predicates in its family tree.
122 later devices descend from it; 3 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K031011: Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 (2003), 114 descendants of its own
- 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
- K123444: Ligasure Impact Curved, Large Jaw, Open Sealer / Divider (2013), 56 descendants of its own

## Recalls of this device
- Jan 27, 2006 · Not classified · Z-0772-06: Sealing cycle may be interrupted during vessel ligation procedure, resulting in an incomplete seal.
- Jan 27, 2006 · Not classified · Z-0773-06: Sealing cycle may be interrupted during vessel ligation procedure, resulting in an incomplete seal.

Source page: https://510kreport.com/device/K010013
Methodology: https://510kreport.com/methodology