# K150735: Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Aug 4, 2015 after 137 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K813071 (1981). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051627: Valleylab G3000 Electrosurgical Instrument, Valleylab (2005) Summary page 4.

## Recalls of this device
- Feb 10, 2020 · Class II · Z-1446-2020: Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.
- Feb 15, 2019 · Class II · Z-1020-2019: Potential for the sterile packaging to be compromised

## Indications for use
The Force TriVerse Electrosurgical Device is a single-use device intended for use in open surgical procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic), and minimally invasive arthroscopic procedures where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The electrosurgical device is intended for use with conventional monopolar electrosurgical electrodes.

Source page: https://510kreport.com/device/K150735
Methodology: https://510kreport.com/methodology