Rigi10 機械式陰莖植入體
K 號：K181673 · 2019-04-15
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器材摘要
Rigi10 Malleable Penile Prosthesis is the device name listed in this FDA 510(k) record. The listed applicant is Rigicon, Inc.. It received FDA 510(k) clearance on 2019-04-15 under 510(k) number K181673. The device is classified under product code FAE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Rigi10 Malleable Penile Prosthesis?
Rigi10 Malleable Penile Prosthesis is a medical device that received FDA 510(k) clearance on 2019-04-15. The listed applicant is Rigicon, Inc.. The 510(k) number is K181673.
When did Rigi10 Malleable Penile Prosthesis receive FDA 510(k) clearance?
Rigi10 Malleable Penile Prosthesis received FDA 510(k) clearance on 2019-04-15, under 510(k) number K181673.
Who is the listed applicant for Rigi10 Malleable Penile Prosthesis?
The FDA 510(k) record lists Rigicon, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Rigi10 Malleable Penile Prosthesis?
The FDA product code for Rigi10 Malleable Penile Prosthesis is FAE.
相關臨床試驗
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相關器械（代碼：FAE）
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。
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。
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