# K160806: Verza Guidance System

- Pathway: 510(k) (Traditional)
- Applicant: CIVCO Medical Instruments Co., Inc.
- Decided: Aug 5, 2016 after 134 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- 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 K882383 (1988). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083667: Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model UA 1336, Needle Guide for 8824, Model UA 1337, B-K Medical Aps (2009) Summary page 4.

## Most influential descendants
- K262474: ND Needle Guidance System (2026), 0 descendants of its own
- K250524: Mendaera Guidance System (2025), 0 descendants of its own

## Indications for use
The system provides guidance for precise instrument placement of common interventional devices by positioning the device relative to the ultrasound transducer and the resulting image during a diagnostic or therapeutic procedure. This guidance system is intended for use with pediatric and adult patients.

Source page: https://510kreport.com/device/K160806
Methodology: https://510kreport.com/methodology