CryoThin™手術系統及配件
K 號：K231661 · 2023-11-27
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決定日期2023-11-27
產品代碼GEH
諮詢委員會SU
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決定相當於
器材摘要
CryoThin™ Surgical System and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Medinux (Tianjin) Technologies Co., Ltd.. It received FDA 510(k) clearance on 2023-11-27 under 510(k) number K231661. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CryoThin™ Surgical System and Accessories?
CryoThin™ Surgical System and Accessories is a medical device that received FDA 510(k) clearance on 2023-11-27. The listed applicant is Medinux (Tianjin) Technologies Co., Ltd.. The 510(k) number is K231661.
When did CryoThin™ Surgical System and Accessories receive FDA 510(k) clearance?
CryoThin™ Surgical System and Accessories received FDA 510(k) clearance on 2023-11-27, under 510(k) number K231661.
Who is the listed applicant for CryoThin™ Surgical System and Accessories?
The FDA 510(k) record lists Medinux (Tianjin) Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CryoThin™ Surgical System and Accessories?
The FDA product code for CryoThin™ Surgical System and Accessories is GEH.
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：GEH）
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
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