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FDA 510(k)

HydroMARK™ Plus 乳腺活检位点标记（蜻蜓形状）；HydroMARK™ Plus 乳腺活检位点标记（蜂鸟形状）

K号: K253761 · 2026-01-23

申请人Devicor Medical Products, Inc.
决定日期2026-01-23
产品代码NEU
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) is the device name listed in this FDA 510(k) record. The listed applicant is Devicor Medical Products, Inc.. It received FDA 510(k) clearance on 2026-01-23 under 510(k) number K253761. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)?

HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) is a medical device that received FDA 510(k) clearance on 2026-01-23. The listed applicant is Devicor Medical Products, Inc.. The 510(k) number is K253761.

When did HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) receive FDA 510(k) clearance?

HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) received FDA 510(k) clearance on 2026-01-23, under 510(k) number K253761.

Who is the listed applicant for HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)?

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

What is the FDA product code for HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)?

The FDA product code for HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) is NEU.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Devicor Medical Products, 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。

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K243095Mammotome AutoCore™ 单次插入式活检系统K240527HydroMARK™ Plus 乳腺活检位点标记（蜂鸟形状）(4010-02-15-T6)K232615LumiMARK™ 活检部位标记 (LM0215T (郁金香形状)); LumiMARK™ 活检部位标记 (LM0215L (莲花形状)); LumiMARK™ 活检部位标记 (LM0215R (玫瑰形状))K221961HydroMARK Plus 乳腺活检位点标记K212158HydroMARK 乳腺活检位点标记

查看所有 14 个设备 →

相关器械（代码：NEU）

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。

K253888MOLLI 2 系统Stryker EndoscopyK252892SCOUT MD 外科引导系统Merit Medical Systems, Inc.K251989VizMark 预装组织标记器设备（VM-0001）Breast-Med, Inc.K251748MammoSTAR活检位点标识器Carbon Medical Technologies, Inc.K243642UltraCor™ Twirl™ 乳腺组织标记器Bard Peripheral Vascular, Inc.K233639SmartClip 安全软组织标记Elucent Medical, Inc.

官方来源

在 FDA 数据库中查看 →

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