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Liberator Beacon Tip Locking Stylet

by Cook Incorporated

510(k) K170298

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 NumberK170298 Date18 Oct 2017ClearedStatusActive

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  • Withdrawn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
DRB
Device Class
Class II
Regulation
21 CFR Part 870.1380
Advisory Committee
Cardiovascular
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 Liberator Beacon Tip Locking Stylet is a stylet used in cardiovascular procedures. It is designed to provide support and shape retention during catheter insertion and navigation.

This device is supplied non-sterile and is intended for single use. It is regulated as a Class II medical device under FDA 510(k) clearance K170298, with product code DRB and regulation number 870.1380.

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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 Liberator Beacon Tip Locking Stylet used for?

    The Liberator Beacon Tip Locking Stylet is used in cardiovascular procedures to provide support and maintain shape retention during catheter insertion and navigation, helping clinicians guide catheters through vascular pathways with greater control and stability.

  • Is the Liberator Beacon Tip Locking Stylet sterile or non-sterile, and is it intended for single use or reuse?

    The device is supplied non-sterile and is intended for single use only, meaning it should not be reprocessed or reused after a procedure to ensure patient safety and device integrity.

  • What regulatory pathway was used for the Liberator Beacon Tip Locking Stylet, and what is its classification?

    The Liberator Beacon Tip Locking Stylet received FDA 510(k) clearance under K170298 and is regulated as a Class II medical device, with product code DRB and regulation number 870.1380, indicating it was found substantially equivalent to a predicate device.