Cleared Special

Marquee? Disposable Core Biopsy Instrument and Instrument Kit

K250032 · Bard Peripheral Vascular, Inc. · General & Plastic Surgery
Jul 2025
Decision
184d
Days
Class 2
Risk

About This 510(k) Submission

K250032 is an FDA 510(k) clearance for the Marquee? Disposable Core Biopsy Instrument and Instrument Kit, a Instrument, Biopsy (Class II — Special Controls, product code KNW), submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on July 10, 2025, 184 days after receiving the submission on January 7, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K250032 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 2025
Decision Date July 10, 2025
Days to Decision 184 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KNW — Instrument, Biopsy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1075

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