FDA 510(k)

AugMENTA 阴莖植入器

K 號：K200073 · 2022-09-30

決定日期2022-09-30

產品代碼MIB

諮詢委員會中文(台灣): 此醫療設備之規範性文件遵循「醫療規範-v1」政策。以下為該文件之翻譯：此醫療設備已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的臨床試驗編號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。該設備的識別碼為XXXXXXXX，相關資訊請參考以下網址：[URL]。公司名稱：[公司名稱] 產品名稱：[產品名稱]

決定相當於

器材摘要

AugMENTA Penile Implant is the device name listed in this FDA 510(k) record. The listed applicant is Augmenta, LLC. It received FDA 510(k) clearance on 2022-09-30 under 510(k) number K200073. The device is classified under product code MIB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AugMENTA Penile Implant?

AugMENTA Penile Implant is a medical device that received FDA 510(k) clearance on 2022-09-30. The listed applicant is Augmenta, LLC. The 510(k) number is K200073.

When did AugMENTA Penile Implant receive FDA 510(k) clearance?

AugMENTA Penile Implant received FDA 510(k) clearance on 2022-09-30, under 510(k) number K200073.

Who is the listed applicant for AugMENTA Penile Implant?

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

What is the FDA product code for AugMENTA Penile Implant?

The FDA product code for AugMENTA Penile Implant is MIB.

相關器械（代碼：MIB）

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。

K241150MISTI矽膠植入物Keosan Trading Co.K223051預成型矽膠塊International Medical Devices, Inc.K222748ShiNeo矽膠植入物Shineo Technology Co., Ltd.K220760預成型陰莖矽膠塊International Medical Devices, Inc.K193392生物西卡矽膠植入物Metalware Technology Corp.K181387預成型陰莖矽膠塊International Medical Devices, Inc.

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。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：MIB）

官方來源