FDA 510(k)

GelPOINT V-Path 經陰道進入平台含後腹膜進入裝置

K 號：K243152 · 2025-10-02

決定日期2025-10-02

產品代碼HEW

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

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.

常見問題

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.

其他以 Applied Medical Resources Corp. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：HEW）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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