# K132184: Acessa Guidance Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Halt Medical, Inc.
- Decided: Apr 28, 2014 after 287 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: 3 generations back to K993944 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121858: The Ablation System, Halt Medical, Inc. (2012) Summary page 1.

## 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/K132184
Methodology: https://510kreport.com/methodology