FDA 510(k)

Compass可调针，配备适配器SRA-1-01和SRA-2-01

K号: K252874 · 2025-10-08

决定日期2025-10-08

产品代码KTI

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决定实质等同

器械摘要

Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 is the device name listed in this FDA 510(k) record. The listed applicant is Serpex Medical, Inc.. It received FDA 510(k) clearance on 2025-10-08 under 510(k) number K252874. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01?

Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 is a medical device that received FDA 510(k) clearance on 2025-10-08. The listed applicant is Serpex Medical, Inc.. The 510(k) number is K252874.

When did Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 receive FDA 510(k) clearance?

Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 received FDA 510(k) clearance on 2025-10-08, under 510(k) number K252874.

Who is the listed applicant for Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01?

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

What is the FDA product code for Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01?

The FDA product code for Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 is KTI.

列明Serpex Medical, Inc.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。

K221206Compass可调针 K221302Recon Steerable Sheath

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。