# K093713: Ultrasound General Purpose Guidance System

- Pathway: 510(k) (Traditional)
- Applicant: Civco Medical Instruments
- Decided: Jan 19, 2010 after 49 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K850478 (1985). 8 ancestors in all.
4 later devices descend from it; 4 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)
- K882383: Maggi Series Ultra. Needle, Biopsy/Catheter Guides, CIVCO Medical Instruments Co., Inc. (1988) Summary page 2.
- K071204: Site-Rite 6 Ultrasound System, Model Site-Rite 6, C.R. Bard, Inc. (2007) Summary page 2.
- K030064: Ilook 25 Needle Guide Attachment and Bracket Assembly, Sonosite,Inc. (2003) Summary page 2.

## Most influential descendants
- K260114: Align® Cover and Pad Guidance Tool (2026), 0 descendants of its own
- K262474: ND Needle Guidance System (2026), 0 descendants of its own
- K171040: Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range (2017), 0 descendants of its own
- K111426: Euclid (TM) Tier 1-GW Access System (2012), 0 descendants of its own

## Recalls of this device
- May 1, 2025 · Class II · Z-1892-2025: During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place.
- Feb 23, 2018 · Class II · Z-2888-2018: A cover failed leak testing during validation testing of new needle guides from a replacement tool.
- Oct 21, 2015 · Class II · Z-0287-2016: Sterility of the product cannot be assured.
- Oct 21, 2015 · Class II · Z-0286-2016: Sterility of the product cannot be assured.
- Oct 21, 2015 · Class II · Z-0288-2016: Sterility of the product cannot be assured.
- Oct 21, 2015 · Class II · Z-0290-2016: Sterility of the product cannot be assured.
- Oct 21, 2015 · Class II · Z-0289-2016: Sterility of the product cannot be assured.

## Indications for use
The guidance system is intended for directing instruments such as catheters, electrodes and needles into a targeted anatomical location of a patient relative to the imaging instrument for percutaneous procedures. Prior to use healthcare workers should be trained in ultrasonography. The following models are included in this submission: MODEL — INTENDED USE Ultra-Pro WIIT Needle Guides Ultra-Pro 3"h Needle Guides AccuSITE Transverse Needle Guides Infiniti Needle Guides Multi-Pro 2000 Needle Guides MAGGI HI Plus Needle Guides — The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.

Source page: https://510kreport.com/device/K093713
Methodology: https://510kreport.com/methodology