# K133578: Reprocessed Ligasure Blunt Tip Laparoscopic Sealer/Divider

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Sustainability Solutions
- Decided: Apr 10, 2014 after 140 days
- Product code: NUJ (Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K090279: Sedecal, Millennium Plus, Sedecal., Sa. (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Reprocessed LigaSure T m Blunt Tip Laparoscopic Sealer/Divider is a bipolar electrosurgical instrument intended for use with the ForceTriadM Energy Platform in general and gynecologic laparoscopic surgical procedures where ligation and division of vessels and lymph is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) 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 procedures where ligation and division of vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplicatlion, colectomny, acihesiolysis, oophorectomy, etc. The device 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 Reprocessed LigaSureM Blunt Tip Laparoscopic Sealer/Divider can be used on vessels and lymphatics up to and including 7mm and tissue bundles as large as will fit in the jaws of the instrument.

Source page: https://510kreport.com/device/K133578
Methodology: https://510kreport.com/methodology