FDA 510(k)

一次性半自动活检器械

K号: K212820 · 2022-07-06

申请人Suzhou Leapmed Healthcare Corporation

决定日期2022-07-06

产品代码KNW

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决定实质等同

器械摘要

Disposable Semi Automatic Biopsy Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Leapmed Healthcare Corporation. It received FDA 510(k) clearance on 2022-07-06 under 510(k) number K212820. 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 Disposable Semi Automatic Biopsy Instrument?

Disposable Semi Automatic Biopsy Instrument is a medical device that received FDA 510(k) clearance on 2022-07-06. The listed applicant is Suzhou Leapmed Healthcare Corporation. The 510(k) number is K212820.

When did Disposable Semi Automatic Biopsy Instrument receive FDA 510(k) clearance?

Disposable Semi Automatic Biopsy Instrument received FDA 510(k) clearance on 2022-07-06, under 510(k) number K212820.

Who is the listed applicant for Disposable Semi Automatic Biopsy Instrument?

The FDA 510(k) record lists Suzhou Leapmed Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Semi Automatic Biopsy Instrument?

The FDA product code for Disposable Semi Automatic Biopsy Instrument is KNW.

列明Suzhou Leapmed Healthcare Corporation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。

K212819一次性活检填充针 K212822一次性同轴活检针 K212284一次性自动芯活检仪器

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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