FDA 510(k)

KARL STORZ內視鏡ICG成像系統

K 號：K152583 · 2016-05-31

決定日期2016-05-31

產品代碼OWN

諮詢委員會GU

決定相當於

器材摘要

KARL STORZ Endoscopic ICG Imaging System 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 2016-05-31 under 510(k) number K152583. 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 Endoscopic ICG Imaging System?

KARL STORZ Endoscopic ICG Imaging System is a medical device that received FDA 510(k) clearance on 2016-05-31. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K152583.

When did KARL STORZ Endoscopic ICG Imaging System receive FDA 510(k) clearance?

KARL STORZ Endoscopic ICG Imaging System received FDA 510(k) clearance on 2016-05-31, under 510(k) number K152583.

Who is the listed applicant for KARL STORZ Endoscopic ICG Imaging System?

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 KARL STORZ Endoscopic ICG Imaging System?

The FDA product code for KARL STORZ Endoscopic ICG Imaging System is OWN.

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：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.K254242KARL STORZ ICG影像系統搭配RUBINA®鏡頭Karl Storz SE & CO. KG K251852cCeLL - 適用於In vivo與Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.K260108L12 LED光源配AIMStryker Endoscopy

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