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FDA 510(k)

ExpressCore Biopsy Device

K-Number: K243886 · 2025-04-29

ApplicantInrad, Inc.
Decision Date2025-04-29
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ExpressCore Biopsy Device is the device name listed in this FDA 510(k) record. The listed applicant is Inrad, Inc.. It received FDA 510(k) clearance on 2025-04-29 under 510(k) number K243886. 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 ExpressCore Biopsy Device?

ExpressCore Biopsy Device is a medical device that received FDA 510(k) clearance on 2025-04-29. The listed applicant is Inrad, Inc.. The 510(k) number is K243886.

When did ExpressCore Biopsy Device receive FDA 510(k) clearance?

ExpressCore Biopsy Device received FDA 510(k) clearance on 2025-04-29, under 510(k) number K243886.

Who is the listed applicant for ExpressCore Biopsy Device?

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

What is the FDA product code for ExpressCore Biopsy Device?

The FDA product code for ExpressCore Biopsy Device is KNW.

Other records listing Inrad, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240429Trilogy Tissue MarkerK183503EasyMark Tissue Marker

Related Devices (Code: KNW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.K260572Marrow MarxmanMedimetrix, LLCK261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.K260365Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery CharDevicor Medical Products, Inc.K252795ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with CoaxialArgon Medical Devices, 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.

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