EndyGel
K 號：K161715 · 2017-02-07
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器材摘要
EndyGel is the device name listed in this FDA 510(k) record. The listed applicant is Endymed Medical, Ltd.. It received FDA 510(k) clearance on 2017-02-07 under 510(k) number K161715. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the EndyGel?
EndyGel is a medical device that received FDA 510(k) clearance on 2017-02-07. The listed applicant is Endymed Medical, Ltd.. The 510(k) number is K161715.
When did EndyGel receive FDA 510(k) clearance?
EndyGel received FDA 510(k) clearance on 2017-02-07, under 510(k) number K161715.
Who is the listed applicant for EndyGel?
The FDA 510(k) record lists Endymed Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EndyGel?
The FDA product code for EndyGel is GYB.
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其他以 Endymed Medical, Ltd. 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。
相關器械（代碼：GYB）
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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