# K181124: Acessa ProVu System

- Pathway: 510(k) (Traditional)
- Applicant: Acessa Health, Inc.
- Decided: Sep 28, 2018 after 151 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: 16 generations back to K924432 (1993). 49 ancestors in all.
No later device cites it as a predicate yet.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132744: Acessa Guidance System, Halt Medical, Inc. (2014) Summary page 4.
- K121858: The Ablation System, Halt Medical, Inc. (2012) Summary page 4.
- K163121: SmartUs EXT-1M/3M, Telemed (2017) Summary page 4.

## Indications for use
The Acessa ProVu System is indicated for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. The Acessa ProVu System includes optional electromagnetic guidance for enhancing the ultrasonic image of the Acessa ProVu Handpiece and for predicting its future path on a computer monitor screen which also shows the ultrasound B-scan image.

Source page: https://510kreport.com/device/K181124
Methodology: https://510kreport.com/methodology