FDA 510(k)

KARL STORZ 兩極切除鏡，配備高頻電纜

K 號：K221893 · 2023-03-17

決定日期2023-03-17

產品代碼FJL

諮詢委員會GU

決定相當於

器材摘要

KARL STORZ Bipolar Resectoscopes with HF Cable is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy America, Inc.. It received FDA 510(k) clearance on 2023-03-17 under 510(k) number K221893. The device is classified under product code FJL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the KARL STORZ Bipolar Resectoscopes with HF Cable?

KARL STORZ Bipolar Resectoscopes with HF Cable is a medical device that received FDA 510(k) clearance on 2023-03-17. The listed applicant is Karl Storz Endoscopy America, Inc.. The 510(k) number is K221893.

When did KARL STORZ Bipolar Resectoscopes with HF Cable receive FDA 510(k) clearance?

KARL STORZ Bipolar Resectoscopes with HF Cable received FDA 510(k) clearance on 2023-03-17, under 510(k) number K221893.

Who is the listed applicant for KARL STORZ Bipolar Resectoscopes with HF Cable?

The FDA 510(k) record lists Karl Storz Endoscopy America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARL STORZ Bipolar Resectoscopes with HF Cable?

The FDA product code for KARL STORZ Bipolar Resectoscopes with HF Cable is FJL.

其他以 Karl Storz Endoscopy America, Inc. 為申請人之記錄

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。

K252624KARL STORZ 喉鏡及配件 K240506KARL STORZ 持架 K223885霍普金斯望遠鏡 K230359KOH超微注射針管（26167NN）；吸引及灌洗針管，長度36cm（37360CP）；吸引及灌洗針管，長度36cm（37360SC）；吸引及灌洗針管，長度36cm（37560LH）；吸引及灌洗針管，長度30cm（37260LH）；KOH超微注射針（26167NA）；穿刺針，LUER-LOCK（26178R）；吸引及灌洗針管，長度43cm（37460LH）；吸引及灌洗針管，長度36cm（37360LH）；穿刺針，直徑1.6mm，長度36cm（26175R）；雙向閥門（26167H）；注射針，LUER-K223520UNIDRIVE SIII 系統 K223923霍普金斯望遠鏡

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相關器械（代碼：FJL）

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。

K232486KARL STORZ 高頻電切鏡，配備高頻電纜Karl Storz SE & CO. KG K230205維洛西昂系統Corinth Medtech, Inc.K191341Veloxion控制器套件、Veloxion流體控制組、Veloxion切除鏡、Veloxion視頻控制單元、Veloxion輪轉架、廢棄物管理管路、組織捕集器、廢棄物管理袋Corinth Medtech, Inc.K190099Veloxion控制器套件、Veloxion流體控制套件、Veloxion切除鏡、Veloxion視頻控制單元、Veloxion輪轉架、廢物管理管路、組織捕集器Corinth Medtech, Inc.K162979維洛西昂系統Corinth Medtech, Inc.

官方來源

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