# K143260: Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Feb 23, 2015 after 102 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
Longest line of descent: 5 generations back to K932293 (1994). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130744: Ligasure 5MM Blunt Tip Laparoscopic Sealer/Divider, Covidien (2013) Summary page 5.
- K123096: Reprocessed Vessel Sealer, Sterilmed, Inc. (2013) Summary page 5.

## Indications for use
The reprocessed vessel sealer/dividers are intended for use in general and gynecological laparoscopic surgical procedures where ligation and division of vessels and lymph is desired. Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation and division of the vessels is performed. These procedures include laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, adhesiolysis, 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 vessel sealer/dividers can be used to on vessels and lymphatics up to and including 7 mm, and tissue bundles.

Source page: https://510kreport.com/device/K143260
Methodology: https://510kreport.com/methodology