FDA 510(k)

HyperSuture延长线

K号: K234079 · 2024-05-10

决定日期2024-05-10

产品代码GAT

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决定实质等同

器械摘要

HyperSuture 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 2024-05-10 under 510(k) number K234079. 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 Extension Line?

HyperSuture Extension Line is a medical device that received FDA 510(k) clearance on 2024-05-10. The listed applicant is Threadstone, LLC. The 510(k) number is K234079.

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

HyperSuture Extension Line received FDA 510(k) clearance on 2024-05-10, under 510(k) number K234079.

Who is the listed applicant for HyperSuture 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 Extension Line?

The FDA product code for HyperSuture 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 K241376HyperSuture全蓝色延长线 K230311HyperSuture

官方来源

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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。