# K121085: Het Bipolar Ligator System

- Pathway: 510(k) (Traditional)
- Applicant: Het Systems, LLC
- Decided: Nov 20, 2012 after 224 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 K923332 (1992). 26 ancestors in all.
2 later devices descend 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)
- K110143: Het Bipolar Electrocautery Forceps, Het Systems, LLC (2011) Summary page 1.
- K950836: Redfield Infrared Coagulator, Hogan & Hartson (1995) Summary page 1.

## Most influential descendants
- K140422: Het Systems, LLC, Het Bipolar Ligator System (2014), 1 descendant of its own
- 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 are 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. The accessory monitor provides power for a temperature sensor and an LED light source mounted on the disposable forceps. The HET Bipolar Electrocautery Forceps and Monitor may be used with the CONMED HYFRECATOR® 2000 or VALLEYLAB SURGISTAT 11RF energy generators.

Source page: https://510kreport.com/device/K121085
Methodology: https://510kreport.com/methodology