# K121858: The Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Halt Medical, Inc.
- Decided: Nov 5, 2012 after 132 days
- Product code: HFG (Coagulator, Laparoscopic, Unipolar (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K993944 (1999). 3 ancestors in all.
9 later devices descend from it; 3 cite 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)
- K094009: Halt 2000GI Electrosurgical RF Ablation System Model Halt 2000GI, Halt Medical, Inc. (2010) Summary page 1.

## Most influential descendants
- 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
- K233848: Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) (2023), 2 descendants of its own

## Indications for use
The Acessa System is indicated for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.

Source page: https://510kreport.com/device/K121858
Methodology: https://510kreport.com/methodology