XCelliStem 黏膜粉末
K 號：K172593 · 2018-03-16
廣告
器材摘要
XCelliStem Wound Powder is the device name listed in this FDA 510(k) record. The listed applicant is Stemsys. It received FDA 510(k) clearance on 2018-03-16 under 510(k) number K172593. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.
常見問題
What is the XCelliStem Wound Powder?
XCelliStem Wound Powder is a medical device that received FDA 510(k) clearance on 2018-03-16. The listed applicant is Stemsys. The 510(k) number is K172593.
When did XCelliStem Wound Powder receive FDA 510(k) clearance?
XCelliStem Wound Powder received FDA 510(k) clearance on 2018-03-16, under 510(k) number K172593.
Who is the listed applicant for XCelliStem Wound Powder?
The FDA 510(k) record lists Stemsys as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for XCelliStem Wound Powder?
The FDA product code for XCelliStem Wound Powder is KGN.
相關臨床試驗
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：KGN）
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。
K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus 外科維網，1cc（CG-01AP）；Accelagen Plus 外科維網，3cc（CG-03AP）；Accelagen Plus 外科維網，5cc（CG-05AP）；Accelagen Plus 外科條，125x25x2mm（CG-125X25AP）；Accelagen Plus 外科條，250x25x2mm（CG-250X25AP）Berkeley Advanced BiomaterialsK260596膠原蛋白傷口粉末Ventris MedicalK260669Endoform皮膚模板Aroa Biosurgery , Ltd.K253521ECMT-100 WMD 医療設備規範文本翻譯：
ECMT-100 WMD 医療設備規範文本Ecm Therapeutics, Inc.K253204催化BioTissue Holdings, 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。
廣告