FDA 510(k)

經陰道進入平台

K 號：K191294 · 2019-09-06

決定日期2019-09-06

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

Transvaginal Access Platform 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 2019-09-06 under 510(k) number K191294. 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 Transvaginal Access Platform?

Transvaginal Access Platform is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K191294.

When did Transvaginal Access Platform receive FDA 510(k) clearance?

Transvaginal Access Platform received FDA 510(k) clearance on 2019-09-06, under 510(k) number K191294.

Who is the listed applicant for Transvaginal Access Platform?

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 Transvaginal Access Platform?

The FDA product code for Transvaginal Access Platform 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。

K252740Voyant® 開放融合設備 (EB240/Open Fusion)K252442Kii結構氣球進入系統 K243152GelPOINT V-Path 經陰道進入平台含後腹膜進入裝置 K201212Voyant開放融合裝置 K200598Voyant 馬里蘭融合設備 K193292Voyant 5mm 融合設備，Voyant 馬里蘭融合設備

查看所有 11 項裝置 →

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。

K243152GelPOINT V-Path 經陰道進入平台含後腹膜進入裝置Applied Medical Resources Corp.K201086Advincula Delineator 子宮操縱器CooperSurgical, Inc.K180429Advincula Delineator 子宮操縱器CooperSurgical, Inc.K161065ColpoWave™ 子宮顯微鏡和 CerviGrip™ 子宮操作器Surgitools Pty , Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。