FDA 510(k)

Marquee™ Disposable Core Biopsy Instrument and Instrument Kit

Numéro K : K250032 · 2025-07-10

Date de décision2025-07-10

Code produitKNW

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Bard Peripheral Vascular, Inc.. The 510(k) number is K250032.

When did Marquee™ Disposable Core Biopsy Instrument and Instrument Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for Marquee™ Disposable Core Biopsy Instrument and Instrument Kit?

The FDA 510(k) record lists Bard Peripheral Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Dispositifs connexes (Code : KNW)

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Source officielle

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