FDA 510(k)

Intracept 骨內神經燬斷系統

K 號：K222281 · 2022-10-26

決定日期2022-10-26

產品代碼GXI

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

Intracept Intraosseous Nerve Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is Relievant Medsystems, Inc.. It received FDA 510(k) clearance on 2022-10-26 under 510(k) number K222281. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Intracept Intraosseous Nerve Ablation System?

Intracept Intraosseous Nerve Ablation System is a medical device that received FDA 510(k) clearance on 2022-10-26. The listed applicant is Relievant Medsystems, Inc.. The 510(k) number is K222281.

When did Intracept Intraosseous Nerve Ablation System receive FDA 510(k) clearance?

Intracept Intraosseous Nerve Ablation System received FDA 510(k) clearance on 2022-10-26, under 510(k) number K222281.

Who is the listed applicant for Intracept Intraosseous Nerve Ablation System?

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

What is the FDA product code for Intracept Intraosseous Nerve Ablation System?

The FDA product code for Intracept Intraosseous Nerve Ablation System is GXI.

其他以 Relievant Medsystems, Inc. 為申請人之記錄

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K213836Intracept 骨內神經燬斷系統

相關器械（代碼：GXI）

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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