# K223158: LigaSure™ XP Maryland Jaw Sealer/Divider

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Jan 23, 2023 after 108 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: 9 generations back to K932293 (1994). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170869: LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated, Covidien (2017) Summary page 4.
- K162941: Ligasure Blunt Tip, Sealer/Divider, Nano-coated, Covidien (2016) Summary page 4.

## Most influential descendants
- K260636: Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating (2026), 0 descendants of its own

## Indications for use
The LigaSure XP Maryland Jaw Sealer/Divider 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 LigaSure XP Maryland Jaw Sealer/Divider 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 LigaSure XP Maryland Jaw Sealer/Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure XP Maryland Jaw Sealer/Divider for these procedures.

Source page: https://510kreport.com/device/K223158
Methodology: https://510kreport.com/methodology