FDA 510(k)

數位克拉斯斯科普系統，數位神經筆系統

K 號：K223615 · 2023-11-21

決定日期2023-11-21

產品代碼GWG

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

Digital ClarusScope System, Digital NeuroPEN System is the device name listed in this FDA 510(k) record. The listed applicant is Clarus Medical, LLC. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K223615. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Digital ClarusScope System, Digital NeuroPEN System?

Digital ClarusScope System, Digital NeuroPEN System is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Clarus Medical, LLC. The 510(k) number is K223615.

When did Digital ClarusScope System, Digital NeuroPEN System receive FDA 510(k) clearance?

Digital ClarusScope System, Digital NeuroPEN System received FDA 510(k) clearance on 2023-11-21, under 510(k) number K223615.

Who is the listed applicant for Digital ClarusScope System, Digital NeuroPEN System?

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

What is the FDA product code for Digital ClarusScope System, Digital NeuroPEN System?

The FDA product code for Digital ClarusScope System, Digital NeuroPEN System is GWG.

其他以 Clarus Medical, LLC 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。

K252790數位ClarusScope系統及數位NeuroPEN系統 K240535Digital ClarusScope 系統；Digital NeuroPEN 系統 K200925Clarus 抽離導管套管

相關器械（代碼：GWG）

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。

K253602精準S 4K 鼻咽鏡Stryker Endoscopy K253679水灌系統Stryker Instruments K243429HJY視覺Next 3D內視鏡視覺系統Hjy Smart Medical Device Co., Ltd.K250752AURORA® 外科內視鏡系統 (ASX15/60); AURORA® 外科內視鏡系統 (ASX15/80)Integra LifeSciences Corporation K233391cCeLL - 適用於體內VPIX Medical, Inc.K232618Aurora 外科內視鏡系統Rebound Therapeutics Corporation

官方來源

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