FDA 510(k)

連接設備與語音控制的OR Hub；配備設備與語音控制的SDC4K資訊管理系統

K 號：K254014 · 2026-01-13

決定日期2026-01-13

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 2026-01-13 under 510(k) number K254014. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control?

Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control is a medical device that received FDA 510(k) clearance on 2026-01-13. The listed applicant is Stryker Endoscopy. The 510(k) number is K254014.

When did Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control receive FDA 510(k) clearance?

Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control received FDA 510(k) clearance on 2026-01-13, under 510(k) number K254014.

Who is the listed applicant for Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control?

FDA 510(k) 記錄將 Stryker Endoscopy 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control?

The FDA product code for Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control is GCJ.

其他以 Stryker Endoscopy 為申請人之記錄

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相關器械（代碼：GCJ）

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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