# K094009: Halt 2000GI Electrosurgical RF Ablation System Model Halt 2000GI

- Pathway: 510(k) (Traditional)
- Applicant: Halt Medical, Inc.
- Decided: Jun 14, 2010 after 168 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: 1 generation back to K993944 (1999). 2 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993944: Rita Model 1500 Electrosurgical Generator, Power Cord,Footswitch,Main Cable, Dispersive Electrode, Rita Medical Systems (1999) Summary page 1.
- K032149: Rita Model 1500X Electrosurgical RF Generator, Rita Medical Systems, Inc. (2003) Summary page 1.

## Most influential descendants
- K121858: The Ablation System (2012), 9 descendants of its own
- K173703: Sonata Sonography-Guided Transcervical Fibroid Ablation System (2018), 6 descendants of its own
- K193516: Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 (2020), 5 descendants of its own
- K211535: Sonata Transcervical Fibroid Ablation System 2.2 (2021), 4 descendants of its own
- K222304: Sonata Transcervical Fibroid Ablation System 2.2 (2022), 3 descendants of its own

## Indications for use
The Halt 2000 G1™ Electrosurgical Radiofrequency Ablation System is indicated for use in percutaneous, laparoscopic, and intraoperative coagulation and ablation of soft tissue.

Source page: https://510kreport.com/device/K094009
Methodology: https://510kreport.com/methodology