FDA 510(k)

KARL STORZ 小兒腎盂-尿道纖維鏡 (11274BCU1)

K 號：K243409 · 2024-11-27

決定日期2024-11-27

產品代碼FBO

諮詢委員會GU

決定相當於

器材摘要

KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) 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 2024-11-27 under 510(k) number K243409. The device is classified under product code FBO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)?

KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) is a medical device that received FDA 510(k) clearance on 2024-11-27. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K243409.

When did KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) receive FDA 510(k) clearance?

KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) received FDA 510(k) clearance on 2024-11-27, under 510(k) number K243409.

Who is the listed applicant for KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)?

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 Pediatric Cysto-Urethro-Fiberscope (11274BCU1)?

The FDA product code for KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) is FBO.

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：FBO）

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。

K244001KARL STORZ 膀胱尿道纖維鏡（11272CU1）；KARL STORZ 膀胱尿道纖維鏡（11272C2）Karl Storz SE & CO. KG

官方來源

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