Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Marquee™ Disposable Core Biopsy Instrument and Instrument Kit

K-Number: K250032 · 2025-07-10

ApplicantBard Peripheral Vascular, Inc.
Decision Date2025-07-10
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Marquee™ Disposable Core Biopsy Instrument and Instrument Kit is a medical device manufactured by Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2025-07-10 under approval number K250032. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Marquee™ Disposable Core Biopsy Instrument and Instrument Kit?

Marquee™ Disposable Core Biopsy Instrument and Instrument Kit is a medical device that received FDA 510(k) clearance on 2025-07-10. It is manufactured by Bard Peripheral Vascular, Inc.. The 510(k) number is K250032.

When was Marquee™ Disposable Core Biopsy Instrument and Instrument Kit approved by the FDA?

Marquee™ Disposable Core Biopsy Instrument and Instrument Kit received FDA 510(k) clearance on 2025-07-10, under approval number K250032.

What company makes Marquee™ Disposable Core Biopsy Instrument and Instrument Kit?

Marquee™ Disposable Core Biopsy Instrument and Instrument Kit is manufactured by Bard Peripheral Vascular, Inc..

What is the FDA product code for Marquee™ Disposable Core Biopsy Instrument and Instrument Kit?

The FDA product code for Marquee™ Disposable Core Biopsy Instrument and Instrument Kit is KNW.

Other Devices by Bard Peripheral Vascular, Inc.

K161986SIDEKICK and USHER Support Catheters K152510UltraCor Twirl Breast Tissue Marker K171953Bard Mission Disposable Core Biopsy Instrument K163420UltraScore Focused Force PTA Balloon K180061UltraCor Twirl Breast Tissue Marker K192948EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G

View all 22 devices →

Related Devices (Code: KNW)

K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer NeedlesM.D.L. S.R.L. K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer StyletDevicor Medical Products, Inc. K161234CASSI II Rotational Core Biopsy SystemScion Medical Technologies, LLC K161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for SemMermaid Medical A/S K161805EnCor MRI Introducer Set, EnCor Probe IntroducerSenorx, Inc. K153337Corvocet Biopsy SystemMerit Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑