FDA 510(k)

Gazelle PTFE和缝合线输送装置

K号: K173335 · 2018-02-08

决定日期2018-02-08

产品代码NBY

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决定实质等同

器械摘要

Gazelle PTFE and Suture Delivery Device is the device name listed in this FDA 510(k) record. The listed applicant is Dura Tap, LLC. It received FDA 510(k) clearance on 2018-02-08 under 510(k) number K173335. The device is classified under product code NBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Gazelle PTFE and Suture Delivery Device?

Gazelle PTFE and Suture Delivery Device is a medical device that received FDA 510(k) clearance on 2018-02-08. The listed applicant is Dura Tap, LLC. The 510(k) number is K173335.

When did Gazelle PTFE and Suture Delivery Device receive FDA 510(k) clearance?

Gazelle PTFE and Suture Delivery Device received FDA 510(k) clearance on 2018-02-08, under 510(k) number K173335.

Who is the listed applicant for Gazelle PTFE and Suture Delivery Device?

The FDA 510(k) record lists Dura Tap, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gazelle PTFE and Suture Delivery Device?

The FDA product code for Gazelle PTFE and Suture Delivery Device is NBY.

列明Dura Tap, LLC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。

K173644Gazelle聚丙烯缝合线和输送装置

官方来源

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