# K140422: Het Systems, LLC, Het Bipolar Ligator System

- Pathway: 510(k) (Traditional)
- Applicant: Het Systems, LLC
- Decided: Jun 5, 2014 after 107 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: 9 generations back to K923332 (1992). 27 ancestors in all.
1 later device descends from it; 1 cites 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)
- K121085: Het Bipolar Ligator System, Het Systems, LLC (2012) Summary page 1.

## Most influential descendants
- K200146: HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor (2020), 0 descendants of its own

## Indications for use
The HET Bipolar Electrocautery Forceps and Monitor is intended to be used for grasping, manipulating and coagulating soft tissue during general surgery. The HET Bipolar Electrocautery Forceps and Monitor may be used for the treatment of symptomatic Grade I and Grade II internal hemorrhoids.

Source page: https://510kreport.com/device/K140422
Methodology: https://510kreport.com/methodology