FDA 510(k)

真迪探針

K 號：K193453 · 2020-03-23

決定日期2020-03-23

產品代碼PGW

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

TruDi Probe is the device name listed in this FDA 510(k) record. The listed applicant is Acclarent, Inc.. It received FDA 510(k) clearance on 2020-03-23 under 510(k) number K193453. 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 TruDi Probe?

TruDi Probe is a medical device that received FDA 510(k) clearance on 2020-03-23. The listed applicant is Acclarent, Inc.. The 510(k) number is K193453.

When did TruDi Probe receive FDA 510(k) clearance?

TruDi Probe received FDA 510(k) clearance on 2020-03-23, under 510(k) number K193453.

Who is the listed applicant for TruDi Probe?

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

What is the FDA product code for TruDi Probe?

The FDA product code for TruDi Probe is PGW.

其他以 Acclarent, 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。

K253612Acclarent AERA 鼻咽管氣球擴張系統 K230742ACCLARENT AERA 鼻咽管擴張系統 K231862TruDi®導航系統V3 (FG-2000-00)K221037TruDi 剃刀刀片 K201115下一代球囊擴張系統 K201174真迪淨治器

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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™ 刀片配自動電磁追蹤功能（187BL4012EM）；ApexCut™ 刀片配自動電磁追蹤功能（187BL4040EM）；ApexCut™ 刀片配自動電磁追蹤功能（187BL4060EM）；ApexCut™ 刀片配自動電磁追蹤功能（187BL2975EM）；ApexCut™ 刀片配自動電磁追蹤功能（187BL3590EM）；ApexCut™ 刀片配自動電磁追蹤功能（187BL4000LEM）Medtronic Xomed, Inc.K261540立方4D導航系統，虛擬眼專業版Fiagon GmbH K253395Stealth AXiS™ 鼻喉科臨床應用Medtronic Navigation, Inc.K243053Navient影像導引導航系統（耳鼻喉科）（955-NC-NC）Claronav K231862TruDi®導航系統V3 (FG-2000-00)Acclarent, Inc.K223734耳鼻喉科用設備Brainlab AG

官方來源

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