# K981916: Ligasure Vessel Sealing System

- Pathway: 510(k) (Traditional)
- Applicant: Valleylab, Inc.
- Decided: Aug 28, 1998 after 88 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: 1 generation back to K932293 (1994). 6 ancestors in all.
202 later devices descend from it; 16 cite it directly.
0 of 209 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944602: Valleylab Force FX, Valleylab, Inc. (1995) Summary page 1.
- K953195: Valleylab Force 300, Valleylab, Inc. (1995) Summary page 1.
- K946177: Valleylab NS 2000 Bipolar Generator System, Valleylab, Inc. (1995) Summary page 1.
- K932293: Cabot Medical Bipolar Cutting Forceps, Cabot Medical Corp. (1994) Summary page 1.
- K946109: Cabot Medical Reusable Bipolar Cutting Forceps, Cabot Medical Corp. (1995) Summary page 1.
- K960009: Storz S2050 Series Bipolar Forceps, Storz Instrument Co. (1996) Summary page 1.
- (no number) Cabot Seitzinger Tripolar Forceps: named in the summary without a submission number

## Most influential descendants
- K051644: Valleylab Forcetriad Electrosurgical Generator (2005), 128 descendants of its own
- K031011: Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 (2003), 114 descendants of its own
- K070162: Forcetriad Electrosurgical Generator; Ligasure Instruments (2007), 102 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

## Indications for use
The LigaSure™ Vessel Sealing System includes a bipolar electrosurgical generator and dedicated bipolar electrosurgical instruments intended for use in general, laparoscopic and gynecologic procedures where ligation of 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 uroclogic, 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 7 mm. and bundles as large as will fit in the jaws of the instruments.

Source page: https://510kreport.com/device/K981916
Methodology: https://510kreport.com/methodology