FDA 510(k)

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress

K 號：K263010 · 2026-09-24

決定日期2026-09-24

產品代碼GWF

諮詢委員會NE

決定Substantially Equivalent

器材摘要

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress is the device name listed in this FDA 510(k) record. The listed applicant is inomed Medizintechnik GmbH. It received FDA 510(k) clearance on 2026-09-24 under 510(k) number K263010. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress?

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress is a medical device that received FDA 510(k) clearance on 2026-09-24. The listed applicant is inomed Medizintechnik GmbH. The 510(k) number is K263010.

When did ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress receive FDA 510(k) clearance?

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress received FDA 510(k) clearance on 2026-09-24, under 510(k) number K263010.

Who is the listed applicant for ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress?

The FDA 510(k) record lists inomed Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress?

The FDA product code for ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress is GWF.

其他以 inomed Medizintechnik GmbH 為申請人之記錄

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相關器械（代碼：GWF）

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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