LumenR 結組織拉開系統
K 號：K153698 · 2016-04-19
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器材摘要
LumenR Tissue Retractor System is the device name listed in this FDA 510(k) record. The listed applicant is Lumenr, LLC. It received FDA 510(k) clearance on 2016-04-19 under 510(k) number K153698. The device is classified under product code ODB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the LumenR Tissue Retractor System?
LumenR Tissue Retractor System is a medical device that received FDA 510(k) clearance on 2016-04-19. The listed applicant is Lumenr, LLC. The 510(k) number is K153698.
When did LumenR Tissue Retractor System receive FDA 510(k) clearance?
LumenR Tissue Retractor System received FDA 510(k) clearance on 2016-04-19, under 510(k) number K153698.
Who is the listed applicant for LumenR Tissue Retractor System?
The FDA 510(k) record lists Lumenr, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LumenR Tissue Retractor System?
The FDA product code for LumenR Tissue Retractor System is ODB.
相關臨床試驗
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相關器械（代碼：ODB）
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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