FDA 510(k)

預成型陰莖矽膠塊

K 號：K162624 · 2017-02-01

決定日期2017-02-01

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

Pre-Formed Penile Silicone Block is the device name listed in this FDA 510(k) record. The listed applicant is International Medical Devices, Inc.. It received FDA 510(k) clearance on 2017-02-01 under 510(k) number K162624. 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 Pre-Formed Penile Silicone Block?

Pre-Formed Penile Silicone Block is a medical device that received FDA 510(k) clearance on 2017-02-01. The listed applicant is International Medical Devices, Inc.. The 510(k) number is K162624.

When did Pre-Formed Penile Silicone Block receive FDA 510(k) clearance?

Pre-Formed Penile Silicone Block received FDA 510(k) clearance on 2017-02-01, under 510(k) number K162624.

Who is the listed applicant for Pre-Formed Penile Silicone Block?

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

What is the FDA product code for Pre-Formed Penile Silicone Block?

The FDA product code for Pre-Formed Penile Silicone Block is MIB.

其他以 International Medical Devices, Inc. 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。

K223051預成型矽膠塊 K220760預成型陰莖矽膠塊 K181387預成型陰莖矽膠塊

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.K200073AugMENTA 阴莖植入器Augmenta, LLC 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.

官方來源

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