Tisuthes 電鋰聚四氟乙烯外科貼片
K 號：K201153 · 2023-06-13
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決定日期2023-06-13
產品代碼OWR
諮詢委員會SU
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決定相當於
器材摘要
Tisuthes e-PTFE Surgical Patch is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Suokang Medical Implants Co., Ltd.. It received FDA 510(k) clearance on 2023-06-13 under 510(k) number K201153. The device is classified under product code OWR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Tisuthes e-PTFE Surgical Patch?
Tisuthes e-PTFE Surgical Patch is a medical device that received FDA 510(k) clearance on 2023-06-13. The listed applicant is Shanghai Suokang Medical Implants Co., Ltd.. The 510(k) number is K201153.
When did Tisuthes e-PTFE Surgical Patch receive FDA 510(k) clearance?
Tisuthes e-PTFE Surgical Patch received FDA 510(k) clearance on 2023-06-13, under 510(k) number K201153.
Who is the listed applicant for Tisuthes e-PTFE Surgical Patch?
The FDA 510(k) record lists Shanghai Suokang Medical Implants Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tisuthes e-PTFE Surgical Patch?
The FDA product code for Tisuthes e-PTFE Surgical Patch is OWR.
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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