AlloX2 Pro組織擴張器
K 號：K214124 · 2023-06-08
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器材摘要
AlloX2 Pro Tissue Expanders is the device name listed in this FDA 510(k) record. The listed applicant is Sientra, Inc.. It received FDA 510(k) clearance on 2023-06-08 under 510(k) number K214124. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.
常見問題
What is the AlloX2 Pro Tissue Expanders?
AlloX2 Pro Tissue Expanders is a medical device that received FDA 510(k) clearance on 2023-06-08. The listed applicant is Sientra, Inc.. The 510(k) number is K214124.
When did AlloX2 Pro Tissue Expanders receive FDA 510(k) clearance?
AlloX2 Pro Tissue Expanders received FDA 510(k) clearance on 2023-06-08, under 510(k) number K214124.
Who is the listed applicant for AlloX2 Pro Tissue Expanders?
The FDA 510(k) record lists Sientra, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AlloX2 Pro Tissue Expanders?
The FDA product code for AlloX2 Pro Tissue Expanders is LCJ.
相關臨床試驗
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其他以 Sientra, 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。
相關器械（代碼：LCJ）
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。
K254126Natrelle 133S 組織擴張器AbbVieK242963MENTOR™ PliaForm™ 乳房組織擴張器 配可縫針摺片Mentor Worldwide, LLCK243836Mentor™ CPX ™ 4 PLUS Enhance 乳房組織擴張器Mentor Worldwide, LLCK241918MENTOR™ CPX™4 PLUS Enhance 乳房組織擴張器Mentor Worldwide, LLCK211676Motiva Flora 平滑絲質組織擴張器Motiva USA, LLCK221127Sientra, Inc. PortfinderSientra, 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。
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