# K173281: LigaSure Exact Dissector, Nano-coated

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Mar 2, 2018 after 137 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.
5 later devices descend from it; 3 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152286: LigaSure Curved, Small Jaw, Open Sealer/Divider, Covidien (2015) Summary page 4.

## Most influential descendants
- K220481: Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) (2022), 1 descendant of its own
- K202917: LigaSure Exact Dissector, Nano-coated (2021), 1 descendant of its own
- K232511: Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) (2024), 0 descendants of its own
- K230255: Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 (2023), 0 descendants of its own
- K203640: CoolSeal Reveal (2021), 0 descendants of its own

## Indications for use
The LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in 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 in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis. The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectomy, and tonsillectomy) for ligation and division of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands. 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/K173281
Methodology: https://510kreport.com/methodology