FDA 510(k)

一次性活检填充针

K号: K212819 · 2022-07-06

申请人Suzhou Leapmed Healthcare Corporation

决定日期2022-07-06

产品代码FCG

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

Disposable Biopsy Refill Needle 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 K212819. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Biopsy Refill Needle?

Disposable Biopsy Refill Needle 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 K212819.

When did Disposable Biopsy Refill Needle receive FDA 510(k) clearance?

Disposable Biopsy Refill Needle received FDA 510(k) clearance on 2022-07-06, under 510(k) number K212819.

Who is the listed applicant for Disposable Biopsy Refill Needle?

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 Biopsy Refill Needle?

The FDA product code for Disposable Biopsy Refill Needle is FCG.

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。

K212820一次性半自动活检器械 K212822一次性同轴活检针 K212284一次性自动芯活检仪器

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。