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TRANS/P Needle Guide

by Civco Medical Instruments Co., Inc.

510(k) K875236

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 NumberK875236 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  • Withdrawn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/P Needle Guide is a medical device designed for use in radiology procedures. It serves as a guide for needle placement during interventional procedures.

This device is supplied by CIVCO Medical Instruments Co., Inc. and is intended for single-use. It has received FDA 510(k) clearance with the product code IYO and is not indicated for MRI use.

Other devices from Civco Medical Instruments Co., Inc.

See all devices from Civco Medical Instruments Co., Inc. →

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/P Needle Guide used for?

    The TRANS/P Needle Guide is designed for use in radiology procedures to guide needle placement during interventional procedures. It helps ensure accurate positioning during medical imaging-guided interventions.

  • Is the TRANS/P Needle Guide reusable or single-use?

    The TRANS/P Needle Guide is intended for single-use only. It should not be reused on multiple patients as this could compromise sterility and device performance.

  • What regulatory approvals does the TRANS/P Needle Guide have?

    The TRANS/P Needle Guide has received FDA 510(k) clearance with product code IYO. It was determined to be substantially equivalent to predicate devices and is not indicated for MRI use.

  • How is the TRANS/P Needle Guide supplied?

    The TRANS/P Needle Guide is supplied by CIVCO Medical Instruments Co., Inc. It comes in a sterile package ready for single-use in interventional radiology procedures.