FDA 510(k)

ExpressCore Biopsy Device

K-Number: K243886 · 2025-04-29

Decision Date2025-04-29

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ExpressCore Biopsy Device is a medical device manufactured by Inrad, Inc.. It received FDA 510(k) clearance on 2025-04-29 under approval 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. It is manufactured by Inrad, Inc.. The 510(k) number is K243886.

When was ExpressCore Biopsy Device approved by the FDA?

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

What company makes ExpressCore Biopsy Device?

ExpressCore Biopsy Device is manufactured by Inrad, Inc..

What is the FDA product code for ExpressCore Biopsy Device?

The FDA product code for ExpressCore Biopsy Device is KNW.

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Other Devices by Inrad, Inc.

K183503EasyMark Tissue Marker K240429Trilogy Tissue Marker

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

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