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Charlie Guidewire (Regular), Charlie Guidewire (Stiff)

by Guidepath Medical, Inc.

510(k) K121398

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

12 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 NumberK121398 Date13 Dec 2012ClearedStatusActive

Recalls

12 recalls · FDA

  • 12 recalls, same reason

    • Terminated Z-1820-2014 FDA Class I initiated 28 May 2014
    • Terminated Z-1818-2014 FDA Class I initiated 28 May 2014
    • Terminated Z-1823-2014 FDA Class I initiated 28 May 2014
    • Terminated Z-1817-2014 FDA Class I initiated 28 May 2014
    • Terminated Z-1813-2014 FDA Class I initiated 28 May 2014
    • Terminated Z-1821-2014 FDA Class I initiated 28 May 2014
    • Terminated Z-1815-2014 FDA Class I initiated 28 May 2014
    • Terminated Z-1816-2014 FDA Class I initiated 28 May 2014
    • Terminated Z-1814-2014 FDA Class I initiated 28 May 2014
    • Terminated Z-1822-2014 FDA Class I initiated 28 May 2014
    • Terminated Z-1819-2014 FDA Class I initiated 28 May 2014
    • Terminated Z-1812-2014 FDA Class I initiated 28 May 2014

    Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

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  • Withdrawn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
DQX
Device Class
Class II
Regulation
21 CFR Part 870.1330
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Charlie Guidewire is a steerable guidewire used to facilitate catheter and interventional device placement during diagnostic or interventional procedures. It consists of a Nitinol core wire with a polymer jacket and hydrophilic coating, with distal tips available in straight or angled configurations and varying stiffness.

The device is supplied by Guidepath Medical, Inc. and received FDA 510(k) clearance under K121398 on December 13, 2012, with a determination of substantial equivalence. It is classified under product code DQX and regulation 870.1330, and was reviewed by the Cardiovascular advisory committee.

Questions

AI-generated answers, 26 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 Charlie Guidewire used for?

    The Charlie Guidewire is used to facilitate catheter and interventional device placement during diagnostic or interventional procedures by providing steerable navigation through vasculature.

  • How is the Charlie Guidewire supplied and what are its key materials?

    The Charlie Guidewire is supplied by Guidepath Medical, Inc. and consists of a Nitinol core wire with a polymer jacket and hydrophilic coating, with distal tips available in straight or angled configurations and varying stiffness options.

  • What regulatory pathway was used for the Charlie Guidewire and when was it cleared?

    The Charlie Guidewire received FDA 510(k) clearance under K121398 on December 13, 2012, with a determination of substantial equivalence to a legally marketed device.