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FDA 510(k)

KARL STORZ NAV1 Electromagnetic Navigation System

K 號：K161555 · 2016-10-21

申請人Karl Storz Endoscopy America, Inc.
決定日期2016-10-21
產品代碼PGW
諮詢委員會NE
決定Substantially Equivalent

器材摘要

KARL STORZ NAV1 Electromagnetic Navigation 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 2016-10-21 under 510(k) number K161555. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the KARL STORZ NAV1 Electromagnetic Navigation System?

KARL STORZ NAV1 Electromagnetic Navigation System is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is Karl Storz Endoscopy America, Inc.. The 510(k) number is K161555.

When did KARL STORZ NAV1 Electromagnetic Navigation System receive FDA 510(k) clearance?

KARL STORZ NAV1 Electromagnetic Navigation System received FDA 510(k) clearance on 2016-10-21, under 510(k) number K161555.

Who is the listed applicant for KARL STORZ NAV1 Electromagnetic Navigation 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 NAV1 Electromagnetic Navigation System?

The FDA product code for KARL STORZ NAV1 Electromagnetic Navigation System is PGW.

相關臨床試驗

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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 Laryngoscopes and AccessoriesK240506KARL STORZ HoldersK223885HOPKINS TelescopesK230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-K223520UNIDRIVE SIII SystemK223923HOPKINS Telescopes

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相關器械（代碼：PGW）

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。

K262235ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexCut ™ Blade with Automated EM Tracking (187BL4060EM);ApexCut ™ Blade with Automated EM Tracking (187BL2975EM);ApexCut ™ Blade with Automated EM Tracking (187BL3590EM);ApexCut ™ Blade with Automated EM Tracking (187BL4000LEM)Medtronic Xomed, Inc.K261540Cube 4D Navigation System, VirtuEye ProFiagon GmbHK253395Stealth AXiS™ ENT clinical applicationMedtronic Navigation, Inc.K243053Navient Image Guided Navigation System (ENT) (955-NC-NC)ClaronavK231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.K223734ENT EMBrainlab AG

官方來源

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