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FDA 510(k)

Intracept 骨內神經燬除系統（RF 探針），Intracept 骨內神經燬除系統（Access Instruments），Relievant RF 產生器

K 號：K190504 · 2019-05-03

申請人Relievant Medsystems
決定日期2019-05-03
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 (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator is the device name listed in this FDA 510(k) record. The listed applicant is Relievant Medsystems. It received FDA 510(k) clearance on 2019-05-03 under 510(k) number K190504. 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 (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator?

Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator is a medical device that received FDA 510(k) clearance on 2019-05-03. The listed applicant is Relievant Medsystems. The 510(k) number is K190504.

When did Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator receive FDA 510(k) clearance?

Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator received FDA 510(k) clearance on 2019-05-03, under 510(k) number K190504.

Who is the listed applicant for Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator?

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

What is the FDA product code for Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator?

The FDA product code for Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator is GXI.

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。

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其他以 Relievant Medsystems 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。

K180369Intracept 骨內神經燬除系統（元件 Intracept RF 探針）K171143相關醫療系統RF發生器K170827INTRACEPT 骨內神經燬除系統K153272INTRACEPT柔軟雙極RF探針及易於存取工具組

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 MEDICALK251802STAR 電波消融系統Merit Medical Systems, Inc.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 MEDICALK250213OptaBlate 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 InstrumentsK241367RF針管Shanghai Samedical & Plastic Instruments Co., Ltd.

官方來源

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