FDA 510(k)

KARL STORZ ICG影像系統搭配RUBINA®鏡頭

K 號：K254242 · 2026-02-26

決定日期2026-02-26

產品代碼OWN

諮詢委員會GU

決定相當於

器材摘要

KARL STORZ ICG Imaging System with RUBINA® Lens 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 2026-02-26 under 510(k) number K254242. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the KARL STORZ ICG Imaging System with RUBINA® Lens?

KARL STORZ ICG Imaging System with RUBINA® Lens is a medical device that received FDA 510(k) clearance on 2026-02-26. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K254242.

When did KARL STORZ ICG Imaging System with RUBINA® Lens receive FDA 510(k) clearance?

KARL STORZ ICG Imaging System with RUBINA® Lens received FDA 510(k) clearance on 2026-02-26, under 510(k) number K254242.

Who is the listed applicant for KARL STORZ ICG Imaging System with RUBINA® Lens?

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 ICG Imaging System with RUBINA® Lens?

The FDA product code for KARL STORZ ICG Imaging System with RUBINA® Lens is OWN.

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：OWN）

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。

K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KG K254180PerfusiX-影像LIMIS Development B.V.K242163智能手術視覺系統SmartsurgN, Inc.K251852cCeLL - 適用於In vivo與Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.K253972影像1 (TC400US)；X至4U轉接器 (TC040)Karl Storz SE & CO. KG K260108L12 LED光源配AIMStryker Endoscopy

官方來源

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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。