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Marquee Disposable Core Biopsy Instrument and Instrument Kit

by Bard Peripheral Vascular, Inc.

510(k) K250032

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK250032 Date10 Jul 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 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  • Withdrawn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
KNW
Device Class
Class II
Regulation
21 CFR Part 876.1075
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Marquee Disposable Core Biopsy Instrument and Instrument Kit is a disposable core biopsy instrument designed for obtaining tissue samples from soft tissue. It is a substantially equivalent device cleared under FDA 510(k) special clearance pathway with product code KNW.

The device is supplied as a sterile, single-use instrument and kit, intended for use in clinical settings for soft tissue biopsy procedures. It is manufactured by Bard Peripheral Vascular, Inc., located in Tempe, AZ, and authorized under FDA 510(k) clearance K250032. No MRI safety information, storage conditions, or reusable characteristics are specified in the provided data.

From the manufacturer

With two firing modes and two penetration depth options, the Marquee™ Disposable Core Biopsy Instrument gives you powerful choices--precisely what you need to handle a wide range of soft tissue biopsy challenges.

Source: bd.com

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Questions

AI-generated answers, 22 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 Marquee Disposable Core Biopsy Instrument used for?

    The Marquee Disposable Core Biopsy Instrument is designed for obtaining tissue samples from soft tissue during clinical biopsy procedures, as stated in its description for use in soft tissue sampling applications.

  • How is the Marquee Disposable Core Biopsy Instrument supplied and is it reusable?

    The device is supplied as a sterile, single-use instrument and kit, meaning it is intended for one-time use only and is not designed for reuse, reprocessing, or resterilization after initial use.

  • What regulatory pathway was used for the Marquee Disposable Core Biopsy Instrument and what is its clearance number?

    The Marquee Disposable Core Biopsy Instrument was cleared under the FDA 510(k) special clearance pathway as a substantially equivalent device, with clearance number K250032 and product code KNW, as indicated in the authorization and specifications data.