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FDA 510(k)

OmniBone™ 骨髓穿刺組合包含電動驅動器，OmniBone™ 骨穿刺組合包含電動驅動器

K 號：K230015 · 2023-06-16

申請人Laurane Medical Sas
決定日期2023-06-16
產品代碼KNW
諮詢委員會GU
決定相當於

器材摘要

OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver is the device name listed in this FDA 510(k) record. The listed applicant is Laurane Medical Sas. It received FDA 510(k) clearance on 2023-06-16 under 510(k) number K230015. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver?

OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Laurane Medical Sas. The 510(k) number is K230015.

When did OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver receive FDA 510(k) clearance?

OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver received FDA 510(k) clearance on 2023-06-16, under 510(k) number K230015.

Who is the listed applicant for OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver?

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

What is the FDA product code for OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver?

The FDA product code for OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver is KNW.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：KNW）

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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