# K132744: Acessa Guidance System

- Pathway: 510(k) (Traditional)
- Applicant: Halt Medical, Inc.
- Decided: May 27, 2014 after 266 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: 4 generations back to K882383 (1988). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121479: AIM, Inneroptic Technology, Inc. (2012) Summary page 1.

## Most influential descendants
- K181124: Acessa ProVu System (2018), 0 descendants of its own

## Indications for use
The Acessa Guidance System Is Indicated for enhancing the ultrasonic image of the Acessa Handpiece and for predicting its future path on a computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound Imaging system. The device Isintended as an optional accessory for use during the Acessa System procedure.

Source page: https://510kreport.com/device/K132744
Methodology: https://510kreport.com/methodology