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Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle Instrument Guide

by Civco Medical Instruments Co., Inc.

510(k) K970514

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970514 Date20 Jun 1997ClearedStatusActive

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2947-2018 FDA Class II initiated 30 Jul 2018
    • Terminated Z-2946-2018 FDA Class II initiated 30 Jul 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.

    • Terminated Z-1054-2008 FDA Unclassified (pre-2012) initiated 16 Jan 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).

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ITX
Device Class
Class II
Regulation
21 CFR Part 892.1570
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a disposable transrectal, transvaginal, and endocavity ultrasound needle instrument guide, classified under the Ultrasound Imaging Device category. It is designed to facilitate precise needle placement during ultrasound-guided procedures, ensuring alignment with imaging planes for enhanced visibility and accuracy. The guide aids in procedures such as tissue biopsy, fluid aspiration, and targeted treatment within confined anatomical cavities. Its construction allows for parallel needle insertion relative to the ultrasound probe, improving procedural guidance and reducing operator error.

The guide is intended for single-use and is supplied sterile to ensure patient safety. It is compatible with standard ultrasound systems and is intended for use in clinical settings such as radiology and gynecology. The device is FDA-cleared under the 510(k) pathway (K970514) and falls under the Radiology advisory committee review. No additional regulatory markings or MRI safety classifications are specified in the available data.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the disposable ultrasound needle instrument guide used for?

    This device is designed to assist in ultrasound-guided procedures such as tissue biopsies, fluid aspiration, and targeted treatments within confined anatomical cavities like the transrectal, transvaginal, or endocavity regions. By aligning the needle parallel to the ultrasound probe, it enhances visibility and accuracy during interventions, reducing the risk of operator error.

  • How is the disposable ultrasound needle instrument guide supplied?

    The guide is supplied sterile and intended for single-use only. This ensures patient safety by minimizing the risk of contamination and cross-infection, which is critical in clinical settings like radiology and gynecology where precision and sterility are paramount.

  • Can this guide be used with any ultrasound system?

    Yes, the disposable ultrasound needle instrument guide is designed to be compatible with standard ultrasound systems. Its universal compatibility allows clinicians to integrate it seamlessly into existing workflows without requiring specialized equipment.

  • Why is single-use important for this device?

    Single-use is essential for maintaining sterility and reducing the risk of infection transmission between patients. Since this guide comes into direct contact with sensitive anatomical areas, its disposable nature ensures each procedure begins with a fresh, uncontaminated instrument, adhering to clinical best practices.

  • What types of procedures benefit most from using this guide?

    The guide is particularly beneficial for procedures requiring precise needle placement within confined spaces, such as transrectal biopsies, transvaginal fluid aspiration, or endocavity treatments. Its alignment feature with the ultrasound probe improves real-time imaging guidance, making it ideal for complex or delicate interventions where accuracy is critical.