# K260636: Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Sustainability Solutions
- Decided: Jun 18, 2026 after 112 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: 10 generations back to K932293 (1994). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223158: LigaSure™ XP Maryland Jaw Sealer/Divider, Covidien, LLC (2023) Summary page 5.

## Indications for use
The Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, thick tissue (tissue bundles), and lymphatics is desired. The Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as colorectal, bariatric, urologic, vascular, thoracic, and gynecologic. These may include, but are not limited to, such procedures as Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, and so forth. The Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the Remanufactured LigaSure XP Maryland Jaw Sealer/Divider without Nano-coating for these procedures.

Source page: https://510kreport.com/device/K260636
Methodology: https://510kreport.com/methodology