FDA 510(k)

KARL STORZ內視鏡附件用於泌尿科

K 號：K252800 · 2026-06-03

決定日期2026-06-03

產品代碼OCZ

諮詢委員會GU

決定相當於

器材摘要

KARL STORZ Endoscopic Accessories for Urology 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 2026-06-03 under 510(k) number K252800. The device is classified under product code OCZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the KARL STORZ Endoscopic Accessories for Urology?

KARL STORZ Endoscopic Accessories for Urology is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K252800.

When did KARL STORZ Endoscopic Accessories for Urology receive FDA 510(k) clearance?

KARL STORZ Endoscopic Accessories for Urology received FDA 510(k) clearance on 2026-06-03, under 510(k) number K252800.

Who is the listed applicant for KARL STORZ Endoscopic Accessories for Urology?

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 Endoscopic Accessories for Urology?

The FDA product code for KARL STORZ Endoscopic Accessories for Urology is OCZ.

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：OCZ）

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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官方來源

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