FDA 510(k)

一次性预校准脑活检针2.0

K号: K230201 · 2023-02-22

决定日期2023-02-22

产品代码HAW

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Disposable Pre-calibrated Brain Biopsy Needle 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2023-02-22 under 510(k) number K230201. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Pre-calibrated Brain Biopsy Needle 2.0?

Disposable Pre-calibrated Brain Biopsy Needle 2.0 is a medical device that received FDA 510(k) clearance on 2023-02-22. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K230201.

When did Disposable Pre-calibrated Brain Biopsy Needle 2.0 receive FDA 510(k) clearance?

Disposable Pre-calibrated Brain Biopsy Needle 2.0 received FDA 510(k) clearance on 2023-02-22, under 510(k) number K230201.

Who is the listed applicant for Disposable Pre-calibrated Brain Biopsy Needle 2.0?

The FDA 510(k) record lists PAJUNK GmbH Medizintechnologie as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Pre-calibrated Brain Biopsy Needle 2.0?

The FDA product code for Disposable Pre-calibrated Brain Biopsy Needle 2.0 is HAW.

列明PAJUNK GmbH Medizintechnologie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。

K243690SonoMSK K243682SonoPlex STIM；SonoPlex II K250774SPROTTE® 标准型 (LUER/ NRFit®) 腰椎穿刺 K243525SonoTAP和SonoTAP II K241953SPROTTE® 标准型 (LUER/ NRFit®) 麻醉学 K241954SonoBlock; SonoBlock II

查看所有 21 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。