FDA 510(k)

ExpressCore活检装置

K号: K243886 · 2025-04-29

决定日期2025-04-29

产品代码KNW

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决定实质等同

器械摘要

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.

常见问题

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.

列明Inrad, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K240429Trilogy 组织标记器 K183503EasyMark Tissue Marker

相关器械（代码：KNW）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260517自动核心活检仪器Zhejiang Curaway Medical Technology Co., Ltd.K262571EnCor EnCompass™乳腺活检和组织移除系统Bard Peripheral Vascular, Inc.K262792Brevera活检系统，配备CorLumina成像技术（BREVDISP09）Hologic, Inc.K260572骨髓马克思曼Medimetrix, LLC K261196Promisemed VeriEcto 自动活检针Promisemed Hangzhou Meditech Co., Ltd.K260365Mammotome Prima™ MR 双真空辅助乳腺活检系统控制模块；Mammotome Prima™ MR 双真空辅助乳腺活检系统一次性探头，8号；Mammotome Prima™ MR 双真空辅助乳腺活检系统一次性靶向套件，8号；Mammotome Prima™ MR 双真空辅助乳腺活检系统脚踏开关；Mammotome Prima™ MR 双真空辅助乳腺活检系统可重复使用的托盘；Mammotome Prima™ MR 双真空辅助乳腺活检系统电池充电器Devicor Medical Products, Inc.

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