FDA 510(k)

STAR 電波消融系統

K 號：K251802 · 2026-02-13

決定日期2026-02-13

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

STAR RF Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K251802. 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 STAR RF Ablation System?

STAR RF Ablation System is a medical device that received FDA 510(k) clearance on 2026-02-13. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K251802.

When did STAR RF Ablation System receive FDA 510(k) clearance?

STAR RF Ablation System received FDA 510(k) clearance on 2026-02-13, under 510(k) number K251802.

Who is the listed applicant for STAR RF Ablation System?

FDA 510(k) 記錄將 Merit Medical Systems, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for STAR RF Ablation System?

The FDA product code for STAR RF Ablation System is GXI.

其他以 Merit Medical Systems, 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：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。

K253907一次性射頻針管ABBOTT MEDICAL K251243OneRF 三叉神經開放式頻率探針Neuroone Medical Technologies Corp.K242841一次性RF電極（RFDE-5/RFDE-10/RFDE-15/RFDE-20）ABBOTT MEDICAL K250213OptaBlate BVN 骨內神經消融系統（10mm 探針單套組）；OptaBlate BVN 骨內神經消融系統（10mm 探針雙套組）Stryker Instruments K241367RF針管Shanghai Samedical & Plastic Instruments Co., Ltd.K222281Intracept 骨內神經燬斷系統Relievant Medsystems, Inc.

官方來源

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