FDA 510(k)

霍普金斯望遠鏡

K 號：K221004 · 2022-12-20

決定日期2022-12-20

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

HOPKINS Telescopes is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy America, Inc.. It received FDA 510(k) clearance on 2022-12-20 under 510(k) number K221004. 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 HOPKINS Telescopes?

HOPKINS Telescopes is a medical device that received FDA 510(k) clearance on 2022-12-20. The listed applicant is Karl Storz Endoscopy America, Inc.. The 510(k) number is K221004.

When did HOPKINS Telescopes receive FDA 510(k) clearance?

HOPKINS Telescopes received FDA 510(k) clearance on 2022-12-20, under 510(k) number K221004.

Who is the listed applicant for HOPKINS Telescopes?

The FDA 510(k) record lists Karl Storz Endoscopy America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOPKINS Telescopes?

The FDA product code for HOPKINS Telescopes is GCJ.

其他以 Karl Storz Endoscopy America, Inc. 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。

K252624KARL STORZ 喉鏡及配件 K240506KARL STORZ 持架 K223885霍普金斯望遠鏡 K230359KOH超微注射針管（26167NN）；吸引及灌洗針管，長度36cm（37360CP）；吸引及灌洗針管，長度36cm（37360SC）；吸引及灌洗針管，長度36cm（37560LH）；吸引及灌洗針管，長度30cm（37260LH）；KOH超微注射針（26167NA）；穿刺針，LUER-LOCK（26178R）；吸引及灌洗針管，長度43cm（37460LH）；吸引及灌洗針管，長度36cm（37360LH）；穿刺針，直徑1.6mm，長度36cm（26175R）；雙向閥門（26167H）；注射針，LUER-K223520UNIDRIVE SIII 系統 K223923霍普金斯望遠鏡

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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。

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE選擇系統Karl Storz SE & CO. KG K260972OEV-271MUH LCD 螢幕；OEV-321MUH LCD 螢幕；OEV-431MUH LCD 螢幕Sony Corporation K261139VereSee (VER150、VER200、VER151、VER201、VER200C 及 VER-100-103)Freyja Healthcare, LLC K253541EZ-Close™（EZ Close Port Site Closing Device、EZ Close MAX Port Site Closing Device、EZ Close II Port Site Closing Device）Medical Impact K261614LED LCD 螢幕 (OEV-271H)Lg Electronics.Inc

官方來源

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