FDA 510(k)

HydroMARK 乳腺活检位点标记

K号: K212158 · 2022-04-21

决定日期2022-04-21

产品代码NEU

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决定实质等同

器械摘要

HydroMARK Breast Biopsy Site Marker 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 2022-04-21 under 510(k) number K212158. 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 Breast Biopsy Site Marker?

HydroMARK Breast Biopsy Site Marker is a medical device that received FDA 510(k) clearance on 2022-04-21. The listed applicant is Devicor Medical Products, Inc.. The 510(k) number is K212158.

When did HydroMARK Breast Biopsy Site Marker receive FDA 510(k) clearance?

HydroMARK Breast Biopsy Site Marker received FDA 510(k) clearance on 2022-04-21, under 510(k) number K212158.

Who is the listed applicant for HydroMARK Breast Biopsy Site Marker?

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 Breast Biopsy Site Marker?

The FDA product code for HydroMARK Breast Biopsy Site Marker is NEU.

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 K253761HydroMARK™ 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）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

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