旋轉外科系統
K 號：K243968 · 2025-10-03
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器材摘要
Revolve Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Revolve Surgical, Inc.. It received FDA 510(k) clearance on 2025-10-03 under 510(k) number K243968. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Revolve Surgical System?
Revolve Surgical System is a medical device that received FDA 510(k) clearance on 2025-10-03. The listed applicant is Revolve Surgical, Inc.. The 510(k) number is K243968.
When did Revolve Surgical System receive FDA 510(k) clearance?
Revolve Surgical System received FDA 510(k) clearance on 2025-10-03, under 510(k) number K243968.
Who is the listed applicant for Revolve Surgical System?
The FDA 510(k) record lists Revolve Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Revolve Surgical System?
The FDA product code for Revolve Surgical System is GCJ.
相關臨床試驗
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相關器械（代碼：GCJ）
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。
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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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