Skip to content

Synchro2 Support Guidewire

by Stryker

510(k) K190843

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 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 · Special NumberK190843 Date1 May 2019ClearedStatusActive

Recalls

8 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-0230-2020 FDA Class II initiated 8 Jun 2018 on shared 510(k) K190843
    • Terminated Z-0229-2020 FDA Class II initiated 8 Jun 2018 on shared 510(k) K190843
    • Terminated Z-0226-2020 FDA Class II initiated 8 Jun 2018 on shared 510(k) K190843
    • Terminated Z-0231-2020 FDA Class II initiated 8 Jun 2018 on shared 510(k) K190843
    • Terminated Z-0232-2020 FDA Class II initiated 8 Jun 2018 on shared 510(k) K190843
    • Terminated Z-0225-2020 FDA Class II initiated 8 Jun 2018 on shared 510(k) K190843
    • Terminated Z-0228-2020 FDA Class II initiated 8 Jun 2018 on shared 510(k) K190843

    The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

    • Terminated Z-0227-2020 FDA Class II initiated 8 Jun 2018 on shared 510(k) K190843

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
MOF
Device class
Class II
Regulation
21 CFR Part 870.1330
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 Synchro2 Support Guidewire is a device intended for general intravascular use, including neurovascular and peripheral vasculatures. It is designed to enhance access and can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature.

The device is supplied in various sizes, including 0.014" x 200cm with a 35cm distal segment. It is manufactured by Stryker and has received FDA 510(k) clearance with the product code MOF. The device is classified as a Class II medical device for cardiovascular use.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Questions

AI-generated answers, 6 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 Synchro2 Support Guidewire used for?

    The Synchro2 Support Guidewire is designed for general intravascular use, including neurovascular and peripheral vasculatures. It enhances access and helps selectively introduce and position catheters and other interventional devices within these vascular systems.

  • What sizes and specifications are available for the Synchro2 Support Guidewire?

    The Synchro2 Support Guidewire is supplied in various sizes, including 0.014" x 200cm with a 35cm distal segment. This specific configuration allows for precise navigation and support during interventional procedures.

  • What is the regulatory status of the Synchro2 Support Guidewire?

    The Synchro2 Support Guidewire has received FDA 510(k) clearance with the product code MOF. It is classified as a Class II medical device for cardiovascular use, indicating it meets specific safety and effectiveness requirements.

  • How is the Synchro2 Support Guidewire supplied and stored?

    The device is supplied in sterile packaging for single-use procedures. It should be stored according to the manufacturer's instructions, typically in a controlled environment away from extreme temperatures and direct sunlight to maintain its integrity and performance.