FDA 510(k)

GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device

K号: K243152 · 2025-10-02

决定日期2025-10-02

产品代码HEW

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决定实质等同

器械摘要

GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2025-10-02 under 510(k) number K243152. The device is classified under product code HEW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device?

GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device is a medical device that received FDA 510(k) clearance on 2025-10-02. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K243152.

When did GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device receive FDA 510(k) clearance?

GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device received FDA 510(k) clearance on 2025-10-02, under 510(k) number K243152.

Who is the listed applicant for GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device?

The FDA 510(k) record lists Applied Medical Resources Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device?

The FDA product code for GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device is HEW.

列明Applied Medical Resources Corp.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。

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