IRISeg
K 號：K251763 · 2025-12-16
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器材摘要
IRISeg is the device name listed in this FDA 510(k) record. The listed applicant is Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2025-12-16 under 510(k) number K251763. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the IRISeg?
IRISeg is a medical device that received FDA 510(k) clearance on 2025-12-16. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K251763.
When did IRISeg receive FDA 510(k) clearance?
IRISeg received FDA 510(k) clearance on 2025-12-16, under 510(k) number K251763.
Who is the listed applicant for IRISeg?
The FDA 510(k) record lists Intuitive Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IRISeg?
The FDA product code for IRISeg is QIH.
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其他以 Intuitive Surgical, Inc. 為申請人之記錄
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相關器械（代碼：QIH）
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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