esolution® 食道拉開器
K 號:K243233 · 2024-11-09
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器材摘要
esolution® Esophageal Retractor is the device name listed in this FDA 510(k) record. The listed applicant is S4 Medical Corp.. It received FDA 510(k) clearance on 2024-11-09 under 510(k) number K243233. The device is classified under product code QXU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the esolution® Esophageal Retractor?
esolution® Esophageal Retractor is a medical device that received FDA 510(k) clearance on 2024-11-09. The listed applicant is S4 Medical Corp.. The 510(k) number is K243233.
When did esolution® Esophageal Retractor receive FDA 510(k) clearance?
esolution® Esophageal Retractor received FDA 510(k) clearance on 2024-11-09, under 510(k) number K243233.
Who is the listed applicant for esolution® Esophageal Retractor?
The FDA 510(k) record lists S4 Medical Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for esolution® Esophageal Retractor?
The FDA product code for esolution® Esophageal Retractor is QXU.
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。
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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