FDA 510(k)

KARL STORZ 高頻電切鏡，配備高頻電纜

K 號：K232486 · 2024-05-07

決定日期2024-05-07

產品代碼FJL

諮詢委員會GU

決定相當於

器材摘要

KARL STORZ Monopolar Resectoscopes with HF Cable is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2024-05-07 under 510(k) number K232486. 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 Monopolar Resectoscopes with HF Cable?

KARL STORZ Monopolar Resectoscopes with HF Cable is a medical device that received FDA 510(k) clearance on 2024-05-07. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K232486.

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

KARL STORZ Monopolar Resectoscopes with HF Cable received FDA 510(k) clearance on 2024-05-07, under 510(k) number K232486.

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

FDA 510(k) 記錄將 Karl Storz SE & CO. KG 列為申請人。這並不單獨確立設備製造商。

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

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

其他以 Karl Storz SE & CO. KG 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。

K254252UNIDRIVE SIII 系統；HOPKINS 望遠鏡 0º (26205AMA) 作業套管 (26205CD) 塞子 (26205OC) 修鬆刀片 (26205SA) 修鬆刀片 (26205SB) 修鬆刀片 (091133-01/-10) 修鬆刀片 (091134-01/-10)K254303KARL STORZ 超環 K261102UNIDRIVE選擇系統 K254299CLEARVISION 灌洗鞘 0° (7241AS)；CLEARVISION 灌洗鞘 30° (7241BS)；CLEARVISION 灌洗鞘 45° (7241FS)K260884UNIDRIVE選擇系統 K254103霍普金斯內視鏡術望遠鏡

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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。

K221893KARL STORZ 兩極切除鏡，配備高頻電纜Karl Storz Endoscopy America, Inc.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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