FDA 510(k)

ClearPointer 光學導航棒

K 號：K233155 · 2024-01-12

決定日期2024-01-12

產品代碼HAW

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

ClearPointer Optical Navigation Wand is the device name listed in this FDA 510(k) record. The listed applicant is ClearPoint Neuro, Inc.. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K233155. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ClearPointer Optical Navigation Wand?

ClearPointer Optical Navigation Wand is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is ClearPoint Neuro, Inc.. The 510(k) number is K233155.

When did ClearPointer Optical Navigation Wand receive FDA 510(k) clearance?

ClearPointer Optical Navigation Wand received FDA 510(k) clearance on 2024-01-12, under 510(k) number K233155.

Who is the listed applicant for ClearPointer Optical Navigation Wand?

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

What is the FDA product code for ClearPointer Optical Navigation Wand?

The FDA product code for ClearPointer Optical Navigation Wand is HAW.

其他以 ClearPoint Neuro, 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。

K243657ClearPoint 系統（軟體版本 3.0）K233703骨锚（NGS-BA-01）K233144ClearPoint 骨螺釘標記點 K233141智能框架 OR K233243ClearPoint 系統（軟體版本 2.2）K232102ClearPoint Array System (版本 1.2)

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相關器械（代碼：HAW）

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。

K253856Geniant Cranial（導航神經外科定位機器人）Koh Young Technology, Inc.K261932萊克塞爾® Vantage 積極定位系統Elekta Solutions AB K253663Zeta導航系統Zeta Surgical, Inc.K253379Stealth AXiS 頭部臨床應用Medtronic Navigation, Inc.K231897神經對齊軟體Medivis, Inc.K251317SOLOPASS 2.0 系統Intravent Medical Partners

官方來源

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