# K170869: LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated

- Pathway: 510(k) (Special)
- Applicant: Covidien
- Decided: Apr 21, 2017 after 29 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: 7 generations back to K932293 (1994). 22 ancestors in all.
11 later devices descend from it; 7 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133338: Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX), Covidien, Formerly Valleylab, A Division of Tyco H (2013) Summary page 4.
- K141153: Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw One Step Stealer/Dividers, Curved, Covidien (2014) Summary page 4.

## Most influential descendants
- K202114: CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20 (2020), 4 descendants of its own
- K203183: CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) (2021), 2 descendants of its own
- K223158: LigaSure™ XP Maryland Jaw Sealer/Divider (2023), 1 descendant of its own
- K211579: CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) (2021), 1 descendant of its own
- K181085: LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated (2018), 1 descendant of its own

## Indications for use
The LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure 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 urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc. The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

Source page: https://510kreport.com/device/K170869
Methodology: https://510kreport.com/methodology