# K261070: LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Sep 15, 2026 after 167 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: 8 generations back to K932293 (1994). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 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 5.

## Indications for use
The LigaSure™ Robotically Assisted Surgery (RAS) Maryland Jaw Vessel Sealer/Divider is a bipolar electrosurgical instrument intended for use with the Hugo™ RAS System where ligation, and division of vessels, thick tissue (tissue bundles), and lymphatics is desired. The LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use with the Hugo™ RAS System during the representative surgical procedures set forth in the Hugo™ RAS System Indications Document and the Hugo™ RAS System User’s Guide Instrument Addendum. The LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider for these procedures.

Source page: https://510kreport.com/device/K261070
Methodology: https://510kreport.com/methodology