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CareFusion Gold Tissue Marker

by Care Fusion

510(k) K141722

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 NumberK141722 Date23 Jan 2015ClearedStatusActive

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  • Withdrawn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
NEU
Device Class
Class II
Regulation
21 CFR Part 878.4300
Advisory Committee
General, Plastic Surgery
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.

The CareFusion Gold Tissue Marker is a radiographic, implantable marker device. It is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

The device is sterile and single-use, consisting of a gold marker and a manual delivery system with a plunger mechanism, stylet, and cannula. The delivery system includes 1cm reference marks and echogenic marks on the distal tip to facilitate ultrasound-guided placement. It is supplied as a finished device and is regulated under FDA 510(k) clearance K141722.

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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 CareFusion Gold Tissue Marker used for?

    It is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures, allowing clinicians to identify tissue locations via imaging.

  • Is the CareFusion Gold Tissue Marker sterile and single-use?

    Yes, the device is supplied sterile and is designed for single-use only, consisting of a gold marker and a manual delivery system with plunger, stylet, and cannula to ensure infection control and prevent reuse.

  • What features does the delivery system include to assist with placement?

    The delivery system includes 1cm reference marks and echogenic marks on the distal tip to facilitate ultrasound-guided placement, helping clinicians accurately position the marker during procedures.

  • How is the CareFusion Gold Tissue Marker supplied and regulated?

    It is supplied as a finished, sterile, single-use device and is regulated under FDA 510(k) clearance K141722, which determined it to be substantially equivalent to a legally marketed predicate device.