# K143654: Valleylab LS10 Generator

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Apr 3, 2015 after 101 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: 6 generations back to K911904 (1991). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110268: Forcetriad Electrosurgical Generator, Covidien Lp, Formerly Know AS Valleylab, A Divison (2011) Summary page 4.

## Indications for use
The Valleylab L.S10, LS Series Single Channel Vessel Sealing Generator is an electrosurgical generator containing LigaSure vessel sealing technology. The vessel sealing function is indicated for use in sealing (fusing) vessels (including pulmonary) up to and including 7mm in diameter, tissue bundles, and lymphatics during general surgery including, but not limited to surgical specialties such as urologic, vascular, thoracic, gynecologic, plastic and reconstructive, and colorectal. Refer to each instrument’s instructions for use (IFU) for additional indications, warnings, and specific contraindications. The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures

Source page: https://510kreport.com/device/K143654
Methodology: https://510kreport.com/methodology