FDA 510(k)

HyperSuture全蓝色延长线

K号: K241376 · 2024-08-09

决定日期2024-08-09

产品代码GAT

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决定实质等同

器械摘要

HyperSuture All Blue Extension Line is the device name listed in this FDA 510(k) record. The listed applicant is Threadstone, LLC. It received FDA 510(k) clearance on 2024-08-09 under 510(k) number K241376. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HyperSuture All Blue Extension Line?

HyperSuture All Blue Extension Line is a medical device that received FDA 510(k) clearance on 2024-08-09. The listed applicant is Threadstone, LLC. The 510(k) number is K241376.

When did HyperSuture All Blue Extension Line receive FDA 510(k) clearance?

HyperSuture All Blue Extension Line received FDA 510(k) clearance on 2024-08-09, under 510(k) number K241376.

Who is the listed applicant for HyperSuture All Blue Extension Line?

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

What is the FDA product code for HyperSuture All Blue Extension Line?

The FDA product code for HyperSuture All Blue Extension Line is GAT.

列明Threadstone, 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。

K254275HyperSuture全绿色延长线 K242201HyperSuture白/绿色延长线 K234079HyperSuture延长线 K230311HyperSuture

官方来源

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