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Trans/R Needle Guide

by Civco Medical Instruments Co., Inc.

510(k) K875128

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK875128 Date15 Apr 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
IYO
Device class
Class II
Regulation
21 CFR Part 892.1560
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

The Trans/R Needle Guide is a needle guide intended for use with ultrasound‑guided interventions, facilitating needle visualization and placement during radiology procedures. It is designed to be used in conjunction with ultrasound probes to improve procedural accuracy.

The device is marketed by CIVCO Medical Instruments Co., Inc. and received FDA 510(k) clearance (decision date 1988‑04‑15, K‑number K875128, product code IYO). It was reviewed by the Radiology advisory committee and is identified as a Class II medical device.

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Questions

AI-generated answers, 23 Sep 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 Trans/R Needle Guide used for?

    The Trans/R Needle Guide is used to facilitate needle visualization and placement during radiology procedures, specifically with ultrasound-guided interventions.

  • Is the Trans/R Needle Guide a single-use device?

    The device data does not specify whether the Trans/R Needle Guide is single-use or reusable, it is recommended to consult the manufacturer's instructions for use.

  • What regulatory clearance does the Trans/R Needle Guide have?

    The Trans/R Needle Guide received FDA 510(k) clearance, which indicates that it is substantially equivalent to a predicate device.