# K970514: Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle Instrument Guide

- Pathway: 510(k) (Traditional)
- Applicant: CIVCO Medical Instruments Co., Inc.
- Decided: Jun 20, 1997 after 129 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K875128 (1988). 2 ancestors in all.
15 later devices descend from it; 4 cite 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)
- K875128: Trans/R Needle Guide, CIVCO Medical Instruments Co., Inc. (1988) Summary page 1.
- K875240: Trans/V Needle Guide, CIVCO Medical Instruments Co., Inc. (1988) Summary page 1.

## Most influential descendants
- K041637: Targetscan Transrectal Ultrasound System (2004), 8 descendants of its own
- K111347: Isrobot Mona Lisa (2011), 4 descendants of its own
- K130944: Isr'obot Mona Lisa (2013), 3 descendants of its own
- K222052: VitroPRO (2022), 2 descendants of its own
- K203659: iSR'obot Mona Lisa 1.0 (2021), 2 descendants of its own

## Recalls of this device
- Jul 30, 2018 · Class II · Z-2946-2018: The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.
- Jul 30, 2018 · Class II · Z-2947-2018: The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.
- Jan 16, 2008 · Not classified · Z-1054-2008: Incorrect Needle Guide- The individual pouches contained V53W Endocavity Needle guide(p/n/034-054) instead of the Shimadzu T/R Needle guide (p/n134-054).

## Indications for use
Diagnostic ultrasound needle / instrument guided procedures - transvaginal and transrectal: tissue biopsy, fluid aspiration, catheter placement, and treatment.

Source page: https://510kreport.com/device/K970514
Methodology: https://510kreport.com/methodology