FDA 510(k)

LCCS 一次性RF電極，LCCS 可重用RF電極

K 號：K152642 · 2016-08-26

決定日期2016-08-26

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

LCCS Disposable RF Electrode, LCCS Reusable RF Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Lccs Products Limited. It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K152642. 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 LCCS Disposable RF Electrode, LCCS Reusable RF Electrode?

LCCS Disposable RF Electrode, LCCS Reusable RF Electrode is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Lccs Products Limited. The 510(k) number is K152642.

When did LCCS Disposable RF Electrode, LCCS Reusable RF Electrode receive FDA 510(k) clearance?

LCCS Disposable RF Electrode, LCCS Reusable RF Electrode received FDA 510(k) clearance on 2016-08-26, under 510(k) number K152642.

Who is the listed applicant for LCCS Disposable RF Electrode, LCCS Reusable RF Electrode?

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

What is the FDA product code for LCCS Disposable RF Electrode, LCCS Reusable RF Electrode?

The FDA product code for LCCS Disposable RF Electrode, LCCS Reusable RF Electrode is GXI.

其他以 Lccs Products Limited 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。

K191293LCCS VC-S RF Cannula

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 K251802STAR 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 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.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。