FDA 510(k)

一次性圆形吻合器

K号: K172561 · 2017-12-05

申请人Changzhou Kangdi Medical Stapler Co., Ltd.

决定日期2017-12-05

产品代码GDW

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决定实质等同

器械摘要

Disposable Circular Stapler is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Kangdi Medical Stapler Co., Ltd.. It received FDA 510(k) clearance on 2017-12-05 under 510(k) number K172561. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Circular Stapler?

Disposable Circular Stapler is a medical device that received FDA 510(k) clearance on 2017-12-05. The listed applicant is Changzhou Kangdi Medical Stapler Co., Ltd.. The 510(k) number is K172561.

When did Disposable Circular Stapler receive FDA 510(k) clearance?

Disposable Circular Stapler received FDA 510(k) clearance on 2017-12-05, under 510(k) number K172561.

Who is the listed applicant for Disposable Circular Stapler?

The FDA 510(k) record lists Changzhou Kangdi Medical Stapler Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Circular Stapler?

The FDA product code for Disposable Circular Stapler is GDW.

列明Changzhou Kangdi Medical Stapler Co., Ltd.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。

K172538一次性线性吻合器，一次性线性切割器

相关器械（代码：GDW）

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。

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