FDA 510(k)

Biopsy Port Adapter

K号: K250145 · 2025-10-17

决定日期2025-10-17

产品代码ODC

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决定实质等同

器械摘要

Biopsy Port Adapter is the device name listed in this FDA 510(k) record. The listed applicant is Endosound, Inc.. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K250145. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Biopsy Port Adapter?

Biopsy Port Adapter is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Endosound, Inc.. The 510(k) number is K250145.

When did Biopsy Port Adapter receive FDA 510(k) clearance?

Biopsy Port Adapter received FDA 510(k) clearance on 2025-10-17, under 510(k) number K250145.

Who is the listed applicant for Biopsy Port Adapter?

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

What is the FDA product code for Biopsy Port Adapter?

The FDA product code for Biopsy Port Adapter is ODC.

列明Endosound, 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。

K232518EndoSound Vision System; EVS

官方来源

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