FiXcision
K 號：K182664 · 2018-12-07
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器材摘要
FiXcision is the device name listed in this FDA 510(k) record. The listed applicant is Agency For Medical Innovations GmbH. It received FDA 510(k) clearance on 2018-12-07 under 510(k) number K182664. The device is classified under product code KOA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the FiXcision?
FiXcision is a medical device that received FDA 510(k) clearance on 2018-12-07. The listed applicant is Agency For Medical Innovations GmbH. The 510(k) number is K182664.
When did FiXcision receive FDA 510(k) clearance?
FiXcision received FDA 510(k) clearance on 2018-12-07, under 510(k) number K182664.
Who is the listed applicant for FiXcision?
The FDA 510(k) record lists Agency For Medical Innovations GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FiXcision?
The FDA product code for FiXcision is KOA.
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其他以 Agency For Medical Innovations GmbH 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。
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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