FDA 510(k)

“POINT” 金導靈活混合導航系統；DRF 適用配件組

K 號：K252989 · 2026-02-20

決定日期2026-02-20

產品代碼OLO

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

“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set is the device name listed in this FDA 510(k) record. The listed applicant is Point Robotics MedTech, Inc.. It received FDA 510(k) clearance on 2026-02-20 under 510(k) number K252989. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set?

“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set is a medical device that received FDA 510(k) clearance on 2026-02-20. The listed applicant is Point Robotics MedTech, Inc.. The 510(k) number is K252989.

When did “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set receive FDA 510(k) clearance?

“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set received FDA 510(k) clearance on 2026-02-20, under 510(k) number K252989.

Who is the listed applicant for “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set?

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

What is the FDA product code for “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set?

The FDA product code for “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set is OLO.

其他以 Point Robotics MedTech, 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。

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相關器械（代碼：OLO）

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。

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官方來源

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