FDA 510(k)

FiberLocker植入物；FiberLocker仪器；FiberLocker动力单元

K号: K253867 · 2026-01-02

决定日期2026-01-02

产品代码OWX

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit is the device name listed in this FDA 510(k) record. The listed applicant is ZuriMED Technologies AG. It received FDA 510(k) clearance on 2026-01-02 under 510(k) number K253867. The device is classified under product code OWX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit?

FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit is a medical device that received FDA 510(k) clearance on 2026-01-02. The listed applicant is ZuriMED Technologies AG. The 510(k) number is K253867.

When did FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit receive FDA 510(k) clearance?

FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit received FDA 510(k) clearance on 2026-01-02, under 510(k) number K253867.

Who is the listed applicant for FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit?

The FDA 510(k) record lists ZuriMED Technologies AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit?

The FDA product code for FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit is OWX.

列明ZuriMED Technologies AG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。

K241219FiberLocker系统：FiberLocker植入物（SpeedPatch PET），FiberLocker仪器（FiberLocker仪器SN）

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。