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FDA 510(k)

NexPort™ Trocar 系統 (TS211001)；NexPort™ Trocar 系統 (TS211002)；NexPort™ Trocar 系統 (TS211003)；NexPort™ Trocar 系統 (TS211010)；NexPort™ Trocar 系統 (TS211011)；NexPort™ Trocar 系統 (TS211012)；NexPort™ Trocar 系統 (TS221001)；NexPort™ Trocar 系統 (TS221002)；NexPort™ Trocar 系統 (TS221003)；NexPort™ Trocar 系統 (TS221010)；NexPort™ Trocar 系統 (TS221011)；NexPort™ Trocar 系統 (TS221012)；NexPort™ Trocar 系統 (TS221020)；NexPort™ Trocar 系統 (TS221021)。

K 號：K232042 · 2023-10-20

申請人Mediconcepts Technology (Shenzhen) Company Limited
決定日期2023-10-20
產品代碼GCJ
諮詢委員會GU
決定相當於

器材摘要

NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021); is the device name listed in this FDA 510(k) record. The listed applicant is Mediconcepts Technology (Shenzhen) Company Limited. It received FDA 510(k) clearance on 2023-10-20 under 510(k) number K232042. 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 NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021);?

NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021); is a medical device that received FDA 510(k) clearance on 2023-10-20. The listed applicant is Mediconcepts Technology (Shenzhen) Company Limited. The 510(k) number is K232042.

When did NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021); receive FDA 510(k) clearance?

NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021); received FDA 510(k) clearance on 2023-10-20, under 510(k) number K232042.

Who is the listed applicant for NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021);?

The FDA 510(k) record lists Mediconcepts Technology (Shenzhen) Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021);?

The FDA product code for NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021); is GCJ.

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。

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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。

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE選擇系統Karl Storz SE & CO. KGK260972OEV-271MUH LCD 螢幕；OEV-321MUH LCD 螢幕；OEV-431MUH LCD 螢幕Sony CorporationK261139VereSee (VER150、VER200、VER151、VER201、VER200C 及 VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™（EZ Close Port Site Closing Device、EZ Close MAX Port Site Closing Device、EZ Close II Port Site Closing Device）Medical ImpactK261614LED LCD 螢幕 (OEV-271H)Lg Electronics.Inc

官方來源

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